A Phase 1 interventional study of Paroxetine IR tablets A and Paroxetine IR tablets B in Anxiety Disorders, sponsored by GlaxoSmithKline. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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Among 24 studies in Anxiety Disorders by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Anxiety Disorders · GlaxoSmithKline.
Among the 24 studies in Anxiety Disorders by GlaxoSmithKline, this one is the 4th largest by enrollment of the 22 interventional ones that give a count, is the only one that started in 2018, is one of 17 in phase 1, and was the 22nd registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →None of the 24 studies in Anxiety Disorders by GlaxoSmithKline is open now. The open studies under Anxiety Disorders, anywhere →
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 85 is close to the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 31 across the 22 interventional studies, 1 across the 1 observational. Of the 24 that completed or were terminated, 3 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 24 studies in Anxiety Disorders by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China. This bioequivalence study will evaluate Paroxetine IR tablets manufactured in GSKT (A) and Mississauga (B) sites in healthy Chinese subjects under fasting and fed conditions to support the quality consistency evaluation. This is a single dose, open-label, randomized, two-period crossover study and will include a screening period (up to 7 days), two open-label treatment periods (up to 16 days) and a follow-up phase (up to 14 days after last-dose). The whole study will be divided into two groups, one for fasting condition enrolling approximately 36 subjects and another for fed condition for which approximately 44 subjects will be enrolled. In both groups, eligible subjects will be randomized to receive single dose of Paroxetine IR tablets A or B in a cross-over manner.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive a single dose of Paroxetine IR tablets A in Period 1 followed by Paroxetine IR tablets B in Period 2 in fasting state.
Drug: Paroxetine IR tablets A · Drug: Paroxetine IR tablets B
Eligible subjects will receive a single dose of Paroxetine IR tablets B in Period 1 followed by Paroxetine IR tablets A in Period 2 in fasting state.
Drug: Paroxetine IR tablets A · Drug: Paroxetine IR tablets B
Eligible subjects will receive a single dose of Paroxetine IR tablets A in Period 1 followed by Paroxetine IR tablets B in Period 2 in fed state.
Drug: Paroxetine IR tablets A · Drug: Paroxetine IR tablets B
Eligible subjects will receive a single dose of Paroxetine IR tablets B in Period 1 followed by Paroxetine IR tablets A in Period 2 in fed state.
Drug: Paroxetine IR tablets A · Drug: Paroxetine IR tablets B
Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.
Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
Time frame: Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
Time frame: Up to Day 26
Number of Participants With Non-SAE and SAEs Under Fasting Condition
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
Time frame: Up to Day 26
Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition
Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: \>=2 times upper limit of normal \[ULN\] units per liter \[U/L\]),albumin (low: \<30 grams per liter),ALP (low: \<20 international units per liter \[IU/L\] and high: \>200 IU/L), AST (high: \>=2 times ULN U/L),calcium (low: \<2 millimoles per liter \[mmol/L\] and high: \>2.75 mmol/L),creatinine (high: \>133 micromoles per liter), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Time frame: Day 16
Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: \>=2 times ULN U/L), albumin (low: \<30 grams per liter), ALP (low: \<20 IU/L and high: \>200 IU/L), AST (high: \>=2 times ULN U/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), creatinine (high: \>133 micromoles per liter), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Time frame: Day 16
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition
Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male\[low: \<0.03 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\] and Female\[low: \<0.04 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\]),Hb(Male \[low: \<110 grams per liter and high: \>180 grams per liter) and Female\[low: \<100 grams per liter and high: \>170 grams per liter\]),erythrocytes(Male \[low: \<4.5x10\^12 cells per liter and high: \>5.5x10\^12 cells per liter\] and Female\[low: \<4 x10\^12 cells per liter and high: \>5 x10\^12 cells per liter\]) and platelets(low: \<80x10\^9 cells per liter and high: \>400x10\^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.
Time frame: Day 16
Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition
Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male \[low: \<0.03 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\] and Female \[low: \<0.04 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\]), Hb (Male \[low: \<110 grams per liter and high: \>180 grams per liter) and Female \[low: \<100 grams per liter and high: \>170 grams per liter\]), erythrocytes (Male \[low: \<4.5x10\^12 cells per liter and high: \>5.5x10\^12 cells per liter\] and Female \[low: \<4 x10\^12 cells per liter and high: \>5 x10\^12 cells per liter\]) and platelets (low: \<80x10\^9 cells per liter and high: \>400x10\^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
Time frame: Day 16
Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition
Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
Time frame: Baseline (Day-7 to Day -1) and Day 16
Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition
Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
Time frame: Baseline (Day-7 to Day -1) and Day 16
Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition
A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:\<50 beats per minute and upper: \>110 beats per minute; QT: Upper: \>400 milliseconds (msec); QTc: Upper: \>450 msec; PR: lower: \<110 msec and upper: \>220 msec; QRS: lower: \<60 msec and upper: \>120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
Time frame: Baseline (Day-7 to Day -1) and Day 16
Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition
A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :\<50 beats per minute and upper: \>110 beats per minute; QT: Upper: \>400 msec; QTc: Upper: \>450 msec; PR: lower: \<110 msec and upper: \>220 msec; QRS: lower: \<60 msec and upper: \>120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
Time frame: Baseline (Day-7 to Day -1) and Day 16
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition
Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16
DBP and SBP at Indicated Time-points Under Fasting Condition
Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16
Pulse Rate (PR) at Indicated Time-points Under Fed Condition
Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16
Pulse Rate (PR) at Indicated Time-points Under Fasting Condition
Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16
Respiratory Rate (RR) at Indicated Time-point Under Fed Condition
Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 11
RR at Indicated Time-point Under Fasting Condition
Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 11
Temperature at Indicated Time-point Under Fed Condition
Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 11
Temperature at Indicated Time-point Under Fasting Condition
Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
Time frame: Day 11
This was a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of Paroxetine immediate release (IR) tablets manufactured in GlaxoSmithKline Tianjin (GSKT) (A) and Mississauga (B) sites in healthy Chinese participants under fasting and fed conditions.
| Milestone | Paroxetine 40 mg, GSKT Followed by Mississauga- Fed | Paroxetine 40 mg, Mississauga Followed by GSKT- Fed | Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted | Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted |
|---|---|---|---|---|
| Started | 23 | 24 | 19 | 19 |
| Completed | 22 | 21 | 19 | 19 |
| Not completed | 1 | 3 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 | 0 |
| Milestone | Paroxetine 40 mg, GSKT Followed by Mississauga- Fed | Paroxetine 40 mg, Mississauga Followed by GSKT- Fed | Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted | Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted |
|---|---|---|---|---|
| Started | 22 | 21 | 19 | 19 |
| Completed | 22 | 21 | 19 | 19 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Paroxetine 40 mg, GSKT Followed by Mississauga- Fed | Paroxetine 40 mg, Mississauga Followed by GSKT- Fed | Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted | Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted |
|---|---|---|---|---|
| Started | 22 | 21 | 19 | 19 |
| Completed | 21 | 20 | 19 | 19 |
| Not completed | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).
| Hour*nanogram per milliliter | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition | 860.54 (728.07 to 1017.12) | 812.49 (687.42 to 960.33) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).
| Hour*nanogram per milliliter | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition | 742.07 (615.82 to 894.21) | 745.22 (618.43 to 898.00) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
| Hour*nanogram per milliliter | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition | 866.85 (733.56 to 1024.36) | 814.75 (689.47 to 962.80) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).
| Hour*nanogram per milliliter | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition | 750.49 (623.30 to 903.64) | 753.83 (626.08 to 907.66) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
| Nanogram per milliliter | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition | 39.95 (35.36 to 45.14) | 39.02 (34.54 to 44.09) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.
| Nanogram per milliliter | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition | 36.86 (32.73 to 41.52) | 36.15 (32.10 to 40.72) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
| Hours | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition | 5.00 (2.0 to 8.1) | 5.00 (2.0 to 8.0) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
| Hours | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition | 5.00 (2.0 to 8.0) | 5.00 (2.0 to 8.1) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
| Per hour | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition | 0.0433 (0.0385 to 0.0487) | 0.0462 (0.0422 to 0.0507) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.
| Per hour | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition | 0.0483 (0.0444 to 0.0525) | 0.0494 (0.0451 to 0.0541) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
| Hours | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition | 16.0002 (14.2232 to 17.9992) | 14.9913 (13.6850 to 16.4223) |
Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.
| Hours | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition | 14.3515 (13.2046 to 15.5980) | 14.0311 (12.8060 to 15.3734) |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Any non-SAEs | 14 | 13 |
| Any SAEs | 0 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Any non-SAEs | 12 | 16 |
| Any SAEs | 0 | 0 |
Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: \>=2 times upper limit of normal \[ULN\] units per liter \[U/L\]),albumin (low: \<30 grams per liter),ALP (low: \<20 international units per liter \[IU/L\] and high: \>200 IU/L), AST (high: \>=2 times ULN U/L),calcium (low: \<2 millimoles per liter \[mmol/L\] and high: \>2.75 mmol/L),creatinine (high: \>133 micromoles per liter), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| ALT, To low | 0 | 0 |
| ALT, To normal or no change | 22 | 22 |
| ALT, To high | 0 | 0 |
| Albumin, To low | 0 | 0 |
| Albumin, To normal or no change | 22 | 22 |
| Albumin, To high | 0 | 0 |
| ALP, To low | 0 | 0 |
| ALP, To normal or no change | 22 | 22 |
| ALP, To high | 0 | 0 |
| AST, To low | 0 | 0 |
| AST, To normal or no change | 22 | 22 |
| AST, To high | 0 | 0 |
| Calcium, To low | 0 | 0 |
| Calcium, To normal or no change | 22 | 22 |
| Calcium, To high | 0 | 0 |
| Creatinine, To low | 0 | 0 |
| Creatinine, To normal or no change | 22 | 22 |
| Creatinine, To high | 0 | 0 |
| Glucose, To low | 0 | 0 |
| Glucose, To normal or no change | 22 | 22 |
| Glucose, To high | 0 | 0 |
| Pot, To low | 0 | 0 |
| Pot, To normal or no change | 22 | 22 |
| Pot, To high | 0 | 0 |
| Sodium, To low | 0 | 0 |
| Sodium, To normal or no change | 22 | 22 |
| Sodium, To high | 0 | 0 |
Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: \>=2 times ULN U/L), albumin (low: \<30 grams per liter), ALP (low: \<20 IU/L and high: \>200 IU/L), AST (high: \>=2 times ULN U/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), creatinine (high: \>133 micromoles per liter), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| ALT, To low | 0 | 0 |
| ALT, To normal or no change | 19 | 19 |
| ALT, To high | 0 | 0 |
| Albumin, To low | 0 | 0 |
| Albumin, To normal or no change | 19 | 19 |
| Albumin, To high | 0 | 0 |
| ALP, To low | 0 | 0 |
| ALP, To normal or no change | 19 | 19 |
| ALP, To high | 0 | 0 |
| AST, To low | 0 | 0 |
| AST, To normal or no change | 19 | 19 |
| AST, To high | 0 | 0 |
| Calcium, To low | 0 | 0 |
| Calcium, To normal or no change | 19 | 19 |
| Calcium, To high | 0 | 0 |
| Creatinine, To low | 0 | 0 |
| Creatinine, To normal or no change | 19 | 19 |
| Creatinine, To high | 0 | 0 |
| Glucose, To low | 0 | 0 |
| Glucose, To normal or no change | 19 | 19 |
| Glucose, To high | 0 | 0 |
| Pot, To low | 0 | 0 |
| Pot, To normal or no change | 19 | 19 |
| Pot, To high | 0 | 0 |
| Sodium, To low | 0 | 0 |
| Sodium, To normal or no change | 19 | 19 |
| Sodium, To high | 0 | 0 |
Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male\[low: \<0.03 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\] and Female\[low: \<0.04 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\]),Hb(Male \[low: \<110 grams per liter and high: \>180 grams per liter) and Female\[low: \<100 grams per liter and high: \>170 grams per liter\]),erythrocytes(Male \[low: \<4.5x10\^12 cells per liter and high: \>5.5x10\^12 cells per liter\] and Female\[low: \<4 x10\^12 cells per liter and high: \>5 x10\^12 cells per liter\]) and platelets(low: \<80x10\^9 cells per liter and high: \>400x10\^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Erythrocytes, To low | 2 | 2 |
| Erythrocytes, To normal or no change | 20 | 19 |
| Erythrocytes, To high | 0 | 1 |
| Hct, To low | 0 | 0 |
| Hct, To normal or no change | 22 | 22 |
| Hct, To high | 0 | 0 |
| Hb, To low | 0 | 0 |
| Hb, To normal or no change | 22 | 22 |
| Hb, To high | 0 | 0 |
| Platelets, To low | 0 | 0 |
| Platelets, To normal or no change | 22 | 22 |
| Platelets, To high | 0 | 0 |
Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male \[low: \<0.03 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\] and Female \[low: \<0.04 proportion of red blood cells in blood and high: \>0.54 proportion of red blood cells in blood\]), Hb (Male \[low: \<110 grams per liter and high: \>180 grams per liter) and Female \[low: \<100 grams per liter and high: \>170 grams per liter\]), erythrocytes (Male \[low: \<4.5x10\^12 cells per liter and high: \>5.5x10\^12 cells per liter\] and Female \[low: \<4 x10\^12 cells per liter and high: \>5 x10\^12 cells per liter\]) and platelets (low: \<80x10\^9 cells per liter and high: \>400x10\^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Erythrocytes, To low | 1 | 0 |
| Erythrocytes, To normal or no change | 18 | 19 |
| Erythrocytes, To high | 0 | 0 |
| Hct, To low | 0 | 0 |
| Hct, To normal or no change | 19 | 19 |
| Hct, To high | 0 | 0 |
| Hb, To low | 0 | 0 |
| Hb, To normal or no change | 19 | 19 |
| Hb, To high | 0 | 0 |
| Platelets, To low | 0 | 0 |
| Platelets, To normal or no change | 19 | 19 |
| Platelets, To high | 0 | 0 |
Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Glucose, Baseline, Negative, n=22,25 | 22 | 25 |
| Glucose, Baseline, Positive, n=22,25 | 0 | 0 |
| Glucose, Day 16, Negative, n=22,22 | 22 | 22 |
| Glucose, Day 16, Positive, n=22,22 | 0 | 0 |
| Ketones, Baseline, Positive, n=22,25 | 2 | 1 |
| Ketones, Baseline, Negative, n=22,25 | 20 | 24 |
| Ketones, Day 16, Positive,n=22,22 | 1 | 0 |
| Ketones, Day 16, Negative,n=22,22 | 21 | 22 |
| Occult blood, Baseline, Positive,n=22,25 | 2 | 3 |
| Occult blood, Baseline, Negative,n=22,25 | 20 | 22 |
| Occult blood, Day 16, Positive,n=22,22 | 5 | 3 |
| Occult blood, Day 16, Negative,n=22,22 | 17 | 19 |
| Protein, Baseline, Negative,n=22,25 | 22 | 25 |
| Protein, Baseline, Positive,n=22,25 | 0 | 0 |
| Protein, Day 16, Positive,n=22,22 | 1 | 0 |
| Protein, Day 16, Negative,n=22,22 | 21 | 22 |
| pH=5, Baseline,n=22,25 | 1 | 4 |
| pH=6, Baseline,n=22,25 | 7 | 5 |
| pH=6.5, Baseline,n=22,25 | 3 | 6 |
| pH=7, Baseline,n=22,25 | 9 | 10 |
| pH=8, Baseline,n=22,25 | 2 | 0 |
| pH=5, Day 16,n=22,22 | 2 | 4 |
| pH=6, Day 16,n=22,22 | 12 | 10 |
| pH=6.5, Day 16,n=22,22 | 4 | 2 |
| pH=7, Day 16,n=22,22 | 4 | 6 |
| pH=8, Day 16,n=22,22 | 0 | 0 |
Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Glucose, Baseline, Negative, | 19 | 19 |
| Glucose, Baseline, Positive, | 0 | 0 |
| Glucose, Day 16, Negative, | 19 | 19 |
| Glucose, Day 16, Positive, | 0 | 0 |
| Ketones, Baseline, Negative | 19 | 19 |
| Ketones, Baseline, Positive | 0 | 0 |
| Ketones, Day 16,Positive | 1 | 1 |
| Ketones, Day 16, Negative | 18 | 18 |
| Occult blood, Baseline, Positive | 0 | 1 |
| Occult blood, Baseline, Negative | 19 | 18 |
| Occult blood, Day 16, Positive | 3 | 1 |
| Occult blood, Day 16, Negative | 16 | 18 |
| Protein, Baseline, Negative | 19 | 19 |
| Protein, Baseline, Positive | 0 | 0 |
| Protein, Day 16, Positive | 0 | 1 |
| Protein, Day 16, Negative | 19 | 18 |
| pH=5, Baseline | 3 | 2 |
| pH=6, Baseline | 2 | 3 |
| pH=6.5, Baseline | 5 | 4 |
| pH=7, Baseline | 6 | 9 |
| pH=8, Baseline | 3 | 1 |
| pH=5, Day 16 | 4 | 6 |
| pH=6, Day 16 | 13 | 11 |
| pH=6.5, Day 16 | 0 | 0 |
| pH=7, Day 16 | 2 | 2 |
| pH=8, Day 16 | 0 | 0 |
A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:\<50 beats per minute and upper: \>110 beats per minute; QT: Upper: \>400 milliseconds (msec); QTc: Upper: \>450 msec; PR: lower: \<110 msec and upper: \>220 msec; QRS: lower: \<60 msec and upper: \>120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Baseline, n=22, 25 | 0 | 0 |
| Day 16, n=22, 22 | 1 | 0 |
A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :\<50 beats per minute and upper: \>110 beats per minute; QT: Upper: \>400 msec; QTc: Upper: \>450 msec; PR: lower: \<110 msec and upper: \>220 msec; QRS: lower: \<60 msec and upper: \>120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.
| Participants | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Baseline | 0 | 0 |
| Day 16 | 0 | 0 |
Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Millimeters of mercury | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| DBP, Day 1 (post-dose), n=23,24 | 70.4 ± 9.27 | 67.8 ± 6.84 |
| DBP, Day 2 (post-dose), n=23,24 | 69.0 ± 7.93 | 66.8 ± 7.38 |
| DBP, Day 3, n=23,24 | 67.7 ± 7.11 | 64.5 ± 5.27 |
| DBP, Day 4, n=23,24 | 67.5 ± 6.68 | 66.1 ± 6.86 |
| DBP, Day 5, n=23,24 | 69.7 ± 6.98 | 68.9 ± 7.31 |
| DBP, Day 11, n=21,22 | 69.9 ± 7.62 | 70.5 ± 8.98 |
| DBP, Day 12 (pre-dose), n=21,22 | 71.2 ± 6.59 | 72.7 ± 7.79 |
| DBP, Day 12 (post-dose), n=20,22 | 69.9 ± 7.71 | 72.2 ± 7.67 |
| DBP, Day 13 (post-dose), n=20,22 | 70.3 ± 6.50 | 72.9 ± 7.75 |
| DBP, Day 14, n=20,22 | 70.3 ± 8.15 | 71.7 ± 7.09 |
| DBP, Day 15, n=20,22 | 68.8 ± 6.14 | 70.4 ± 7.10 |
| DBP, Day 16, n=20,22 | 72.8 ± 8.42 | 73.9 ± 6.65 |
| SBP, Day 1 (post-dose), n=23,24 | 112.4 ± 10.13 | 111.8 ± 11.15 |
| SBP, Day 2 (post-dose), n=23,24 | 113.8 ± 9.07 | 111.0 ± 10.19 |
| SBP, Day 3, n=23,24 | 112.9 ± 9.46 | 109.4 ± 10.52 |
| SBP, Day 4, n=23,24 | 111.1 ± 10.83 | 110.9 ± 10.97 |
| SBP, Day 5, n=23,24 | 109.2 ± 10.31 | 109.8 ± 10.08 |
| SBP, Day 11, n=21,22 | 109.0 ± 10.89 | 110.6 ± 9.18 |
| SBP, Day 12 (pre-dose), n=21,22 | 107.2 ± 9.54 | 108.5 ± 8.34 |
| SBP, Day 12 (post-dose), n=20,22 | 112.4 ± 9.66 | 112.4 ± 11.42 |
| SBP, Day 13 (post-dose), n=20,22 | 111.4 ± 10.18 | 112.0 ± 8.80 |
| SBP, Day 14, n=20,22 | 107.0 ± 9.49 | 105.5 ± 8.44 |
| SBP, Day 15, n=20,22 | 107.3 ± 7.73 | 106.0 ± 9.62 |
| SBP, Day 16, n=20,22 | 107.1 ± 8.94 | 105.9 ± 6.29 |
Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Millimeters of mercury | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| DBP, Day 1 (post-dose) | 71.8 ± 6.37 | 70.9 ± 6.56 |
| DBP, Day 2 (post-dose) | 68.3 ± 7.59 | 68.7 ± 7.61 |
| DBP, Day 3 | 66.2 ± 6.99 | 67.8 ± 9.22 |
| DBP, Day 4 | 68.3 ± 8.29 | 68.8 ± 5.91 |
| DBP, Day 5 | 68.1 ± 6.16 | 73.3 ± 7.31 |
| DBP, Day 11 | 71.9 ± 6.62 | 71.4 ± 7.36 |
| DBP, Day 12 (pre-dose) | 72.6 ± 8.00 | 71.2 ± 9.11 |
| DBP, Day 12 (post-dose) | 73.5 ± 6.29 | 70.3 ± 7.59 |
| DBP, Day 13 (post-dose) | 72.6 ± 6.72 | 69.6 ± 7.22 |
| DBP, Day 14 | 72.2 ± 6.96 | 70.2 ± 4.76 |
| DBP, Day 15 | 70.6 ± 7.65 | 68.7 ± 8.39 |
| DBP, Day 16 | 71.9 ± 7.32 | 71.1 ± 8.28 |
| SBP, Day 1 (post-dose) | 107.4 ± 10.56 | 109.2 ± 10.82 |
| SBP, Day 2 (post-dose) | 108.1 ± 11.85 | 110.1 ± 10.13 |
| SBP, Day 3 | 106.3 ± 10.19 | 108.2 ± 12.21 |
| SBP, Day 4 | 105.1 ± 10.31 | 107.4 ± 8.78 |
| SBP, Day 5 | 104.4 ± 9.17 | 111.3 ± 12.03 |
| SBP, Day 11 | 113.2 ± 13.72 | 111.4 ± 12.88 |
| SBP, Day 12 (pre-dose) | 108.3 ± 10.40 | 107.4 ± 9.63 |
| SBP, Day 12 (post-dose) | 111.6 ± 9.63 | 107.5 ± 8.84 |
| SBP, Day 13 (post-dose) | 111.7 ± 10.50 | 109.9 ± 11.86 |
| SBP, Day 14 | 110.5 ± 12.18 | 104.5 ± 9.48 |
| SBP, Day 15 | 108.5 ± 10.56 | 107.4 ± 9.63 |
| SBP, Day 16 | 110.7 ± 12.70 | 104.2 ± 9.65 |
Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Beats per minute | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Day 1 (post-dose), n=23,24 | 72.3 ± 10.57 | 72.0 ± 8.83 |
| Day 2 (post-dose), n=23,24 | 72.8 ± 8.22 | 74.1 ± 9.98 |
| Day 3, n=23,24 | 74.0 ± 9.11 | 75.8 ± 10.07 |
| Day 4, n=23,24 | 75.5 ± 7.13 | 75.7 ± 11.02 |
| Day 5, n=23,24 | 68.7 ± 7.03 | 68.3 ± 8.87 |
| Day 11, n=21,22 | 75.0 ± 11.05 | 77.7 ± 8.38 |
| Day 12 (pre-dose), n=21,22 | 65.8 ± 9.00 | 64.7 ± 7.57 |
| Day 12 (post-dose), n=20,22 | 72.8 ± 10.85 | 76.2 ± 10.15 |
| Day 13 (post-dose), n=20,22 | 73.7 ± 11.86 | 73.8 ± 8.07 |
| Day 14, n=20,22 | 75.6 ± 10.72 | 77.6 ± 9.88 |
| Day 15, n=20,22 | 77.5 ± 11.33 | 75.5 ± 8.38 |
| Day 16, n=20,22 | 69.4 ± 8.54 | 72.6 ± 9.51 |
Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Beats per minute | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Day 1 (post-dose) | 65.4 ± 8.80 | 67.5 ± 7.19 |
| Day 2 (post-dose) | 74.8 ± 7.40 | 75.3 ± 8.31 |
| Day 3 | 74.9 ± 8.45 | 77.2 ± 10.69 |
| Day 4 | 74.2 ± 8.74 | 72.8 ± 9.86 |
| Day 5 | 67.3 ± 6.82 | 71.2 ± 9.60 |
| Day 11 | 81.8 ± 9.72 | 84.1 ± 9.20 |
| Day 12 (pre-dose) | 66.5 ± 8.73 | 66.8 ± 10.48 |
| Day 12 (post-dose) | 67.5 ± 8.96 | 65.2 ± 7.19 |
| Day 13 (post-dose) | 78.1 ± 11.03 | 75.4 ± 7.54 |
| Day 14 | 78.9 ± 11.12 | 76.8 ± 8.25 |
| Day 15 | 78.2 ± 8.38 | 75.9 ± 9.58 |
| Day 16 | 75.7 ± 10.39 | 71.3 ± 7.92 |
Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Breaths per minute | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Respiratory Rate (RR) at Indicated Time-point Under Fed Condition | 17.8 ± 1.78 | 18.6 ± 1.79 |
Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Breaths per minute | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| RR at Indicated Time-point Under Fasting Condition | 19.2 ± 1.38 | 19.4 ± 1.16 |
Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Celsius | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed |
|---|---|---|
| Temperature at Indicated Time-point Under Fed Condition | 36.70 ± 0.307 | 36.59 ± 0.333 |
Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.
| Celsius | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|
| Temperature at Indicated Time-point Under Fasting Condition | 36.84 ± 0.187 | 36.74 ± 0.256 |
Collected over Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 26.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paroxetine 40 mg, GSKT- Fed | 0/44 (0%) | 0/44 (0%) | 14/44 (31.8%) |
| Paroxetine 40 mg, Mississauga- Fed | 0/46 (0%) | 0/46 (0%) | 13/46 (28.3%) |
| Paroxetine 40 mg, GSKT- Fasted | 0/38 (0%) | 0/38 (0%) | 12/38 (31.6%) |
| Paroxetine 40 mg, Mississauga- Fasted | 0/38 (0%) | 0/38 (0%) | 16/38 (42.1%) |
| Event | Paroxetine 40 mg, GSKT- Fed | Paroxetine 40 mg, Mississauga- Fed | Paroxetine 40 mg, GSKT- Fasted | Paroxetine 40 mg, Mississauga- Fasted |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/44 | 1/46 | 5/38 | 6/38 |
| DizzinessNervous system disorders | 1/44 | 0/46 | 6/38 | 4/38 |
| HeadacheNervous system disorders | 2/44 | 0/46 | 0/38 | 5/38 |
| White blood cells urine positiveInvestigations | 1/44 | 1/46 | 3/38 | 3/38 |
| DiarrhoeaGastrointestinal disorders | 3/44 | 2/46 | 0/38 | 2/38 |
| White blood cell count decreasedInvestigations | 0/44 | 3/46 | 1/38 | 0/38 |
| Bacterial testInvestigations | 1/44 | 1/46 | 2/38 | 1/38 |
| VomitingGastrointestinal disorders | 1/44 | 0/46 | 0/38 | 2/38 |
| Bacterial test positiveInvestigations | 0/44 | 0/46 | 0/38 | 2/38 |
| Abdominal painGastrointestinal disorders | 0/44 | 0/46 | 0/38 | 2/38 |
| Age, Continuous(Years) | Paroxetine 40 mg, GSKT Followed by Mississauga- Fed | Paroxetine 40 mg, Mississauga Followed by GSKT- Fed | Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted | Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted | Total |
|---|---|---|---|---|---|
| Mean | 30.3 ± 7.53 | 27.1 ± 5.63 | 25.4 ± 5.86 | 28.1 ± 6.17 | 27.3 ± 6.46 |
| Sex: Female, Male(Participants) | Paroxetine 40 mg, GSKT Followed by Mississauga- Fed | Paroxetine 40 mg, Mississauga Followed by GSKT- Fed | Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted | Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted | Total |
|---|---|---|---|---|---|
| Female | 11 | 10 | 9 | 10 | 40 |
| Male | 12 | 14 | 10 | 9 | 45 |
| Race/Ethnicity, Customized(Participants) | Paroxetine 40 mg, GSKT Followed by Mississauga- Fed | Paroxetine 40 mg, Mississauga Followed by GSKT- Fed | Paroxetine 40 mg, GSKT Followed by Mississauga- Fasted | Paroxetine 40 mg, Mississauga Followed by GSKT- Fasted | Total |
|---|---|---|---|---|---|
| Race — Asian - East Asian Heritage | 23 | 24 | 19 | 19 | 85 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from May 2018 to primary completion in Aug 2018, 2 months.
Results were first posted in Aug 2019, 1 year after primary completion.
Of 71 phase 1 interventional studies under Anxiety Disorders, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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