A Phase 1 interventional study of Test formulation A and Reference formulation B in Infections, Bacterial, sponsored by GlaxoSmithKline. Completed at 1 site in South Africa. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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Among 35 studies in Bacterial Infections by GlaxoSmithKline — 1 open to participants now, 1 under way, none of them phase 3. Bacterial Infections · GlaxoSmithKline.
Among the 35 studies in Bacterial Infections by GlaxoSmithKline, this one is the 17th largest by enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2018, is one of 28 in phase 1, and was the 29th registered.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
Browse Bacterial Infections studies →1 of the 35 studies in Bacterial Infections by GlaxoSmithKline is open now, in 1 country. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States
Ages 2–11
By country, each count listing its studies:
Of the 57 Bacterial Infections studies recruiting now, 38 (67%) set no upper age limit and 14 (25%) stop at 75 or younger; 19 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
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35 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28 is below the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Median enrollment 28 across the 33 interventional studies, 130 across the 2 observational. Of the 29 that completed or were terminated, 13 (45%) 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.
1 of the studies in Bacterial Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07371429GlaxoSmithKlineA Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics | 2027-08-23 |
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Among the 35 studies in Bacterial Infections by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study is open-label, randomized two-way cross-over study to determine if cefixime 200 mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200 mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult subjects under fasting conditions. There will be two treatment periods and each subject will participate in both periods. The washout period between both treatment periods will be 7-14 days. Subjects will be randomized to either of treatment sequences of reference followed by test or test followed by reference to receive a single dose of test or reference formulation on Day 1 in each treatment period. The study will last for 5 to 7 weeks.
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.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
Subjects will be randomized to receive single dose of Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 1 and Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.
Drug: Test formulation A · Drug: Reference formulation B
Subjects will be randomized to receive single dose of Reference formulation (cefixime 200 mg/5 mL) on Day 1 of the treatment period 1 and Test formulation (SKF101804: cefixime 200 mg/ 5 mL) on Day 1 of the treatment period 2. There will be wash out period of 7-14 days between the two treatment periods.
Drug: Test formulation A · Drug: Reference formulation B
Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.
Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor.
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Time of Occurrence of Cmax (Tmax) for Cefixime
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Terminal Phase Half-life (T1/2) for Cefixime
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Time frame: Up to Day 16 in each treatment period
Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.
Time frame: Day -1 and Day 2 of each treatment period
Blood Urea Nitrogen (BUN) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.
Time frame: Day -1 and Day 2 of each treatment period
Calcium, Glucose, Potassium and Sodium at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.
Time frame: Day -1 and Day 2 of each treatment period
Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.
Time frame: Day -1 and Day 2 of each treatment period
Total Protein at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.
Time frame: Day -1 and Day 2 of each treatment period
Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.
Time frame: Day -1 and Day 2 of each treatment period
Mean Corpuscular Volume (MCV) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.
Time frame: Day -1 and Day 2 of each treatment period
Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.
Time frame: Day -1 and Day 2 of each treatment period
Erythrocyte Count at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.
Time frame: Day -1 and Day 2 of each treatment period
Hematocrit at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.
Time frame: Day -1 and Day 2 of each treatment period
Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.
Time frame: Day -1 and Day 2 of each treatment period
Percent Reticulocytes at Indicated Time-points
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.
Time frame: Day -1 and Day 2 of each treatment period
Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis
Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.
Time frame: Day -1 and Day 2 of each treatment period
Respiratory Rate at Indicated Time-points
Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Pulse Rate at Indicated Time-points
Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Body Temperature at Indicated Time-points
Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time frame: Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.
| Milestone | SKF101804 Cefixime Followed by Cefixime Reference Formulation | Cefixime Reference Formulation Followed by SKF101804 Cefixime |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
| Milestone | SKF101804 Cefixime Followed by Cefixime Reference Formulation | Cefixime Reference Formulation Followed by SKF101804 Cefixime |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
| Milestone | SKF101804 Cefixime Followed by Cefixime Reference Formulation | Cefixime Reference Formulation Followed by SKF101804 Cefixime |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 14 |
| Not completed | 0 | 0 |
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
| Hour*nanogram per milliliter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime | 20000 ± 32.9 | 19000 ± 34.3 |
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
| Nanogram per milliliter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime | 2670 ± 29.4 | 2640 ± 30.5 |
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
| Hour*nanogram per milliliter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime | 20700 ± 31.8 | 19700 ± 33.3 |
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.
| Hours | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Time of Occurrence of Cmax (Tmax) for Cefixime | 4.005 (2.50 to 6.02) | 4.005 (2.02 to 4.51) |
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
| Percentage of AUCex | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime | 3.24 ± 51.4 | 3.32 ± 67.8 |
Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
| Hours | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Terminal Phase Half-life (T1/2) for Cefixime | 3.18 ± 15.0 | 3.13 ± 14.7 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
| Participants | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Non-serious AEs | 0 | 0 |
| SAEs | 0 | 0 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.
| Units per liter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| ALT; Period 1; Day -1, 24 Hours Pre-dose | 16.6 ± 10.23 | 15.6 ± 5.67 |
| ALT; Period 1; Day 2, 24 Hours Post-dose | 13.6 ± 7.09 | 14.0 ± 5.76 |
| ALT; Period 2; Day -1, 24 Hours Pre-dose | 16.4 ± 8.98 | 16.7 ± 9.15 |
| ALT; Period 2; Day 2, 24 Hours Post-dose | 14.1 ± 7.07 | 14.9 ± 7.68 |
| ALP; Period 1; Day -1, 24 Hours Pre-dose | 80.4 ± 12.85 | 74.8 ± 18.25 |
| ALP; Period 1; Day 2, 24 Hours Post-dose | 75.5 ± 14.27 | 67.1 ± 15.23 |
| ALP; Period 2; Day -1, 24 Hours Pre-dose | 72.4 ± 17.58 | 80.9 ± 15.81 |
| ALP; Period 2; Day 2, 24 Hours Post-dose | 69.7 ± 16.96 | 76.9 ± 15.13 |
| AST; Period 1; Day -1, 24 Hours Pre-dose | 20.9 ± 4.40 | 20.6 ± 4.22 |
| AST; Period 1; Day 2, 24 Hours Post-dose | 16.7 ± 2.64 | 17.1 ± 3.45 |
| AST; Period 2; Day -1, 24 Hours Pre-dose | 20.5 ± 6.00 | 19.9 ± 4.57 |
| AST; Period 2; Day 2, 24 Hours Post-dose | 16.8 ± 3.75 | 17.8 ± 4.08 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.
| Milligrams per deciliter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 10.354 ± 1.972 | 10.300 ± 4.120 |
| Period 1; Day 2, 24 Hours Post-dose | 12.945 ± 2.349 | 12.258 ± 2.664 |
| Period 2; Day -1, 24 Hours Pre-dose | 10.841 ± 3.571 | 11.844 ± 2.017 |
| Period 2; Day 2, 24 Hours Post-dose | 12.041 ± 2.166 | 12.796 ± 1.599 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.
| Millimoles per liter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Calcium;Period 1;Day -1, 24 Hours Pre-dose | 2.393 ± 0.059 | 2.399 ± 0.134 |
| Calcium;Period 1;Day 2, 24 Hours Post-dose | 2.308 ± 0.068 | 2.304 ± 0.076 |
| Calcium;Period 2;Day -1, 24 Hours Pre-dose | 2.364 ± 0.099 | 2.376 ± 0.060 |
| Calcium;Period 2;Day 2, 24 Hours Post-dose | 2.351 ± 0.087 | 2.378 ± 0.081 |
| Glucose;Period 1;Day -1, 24 Hours Pre-dose | 4.684 ± 0.256 | 4.616 ± 0.267 |
| Glucose;Period 1;Day 2, 24 Hours Post-dose | 4.728 ± 0.229 | 4.676 ± 0.295 |
| Glucose;Period 2;Day -1, 24 Hours Pre-dose | 4.521 ± 0.347 | 4.571 ± 0.404 |
| Glucose;Period 2;Day 2, 24 Hours Post-dose | 4.851 ± 0.375 | 4.812 ± 0.278 |
| Sodium;Period 1;Day -1, 24 Hours Pre-dose | 143.86 ± 1.460 | 145.00 ± 1.414 |
| Sodium;Period 1;Day 2, 24 Hours Post-dose | 141.07 ± 1.439 | 141.43 ± 1.604 |
| Sodium;Period 2;Day -1, 24 Hours Pre-dose | 141.21 ± 1.251 | 141.50 ± 1.912 |
| Sodium;Period 2;Day 2, 24 Hours Post-dose | 139.43 ± 1.089 | 139.64 ± 1.550 |
| Potassium;Period1;Day -1, 24 Hours Pre-dose | 4.634 ± 0.457 | 4.404 ± 0.316 |
| Potassium;Period1;Day 2, 24 Hours Post-dose | 4.522 ± 0.444 | 4.286 ± 0.206 |
| Potassium;Period 2;Day -1, 24 Hours Pre-dose | 4.371 ± 0.220 | 4.521 ± 0.346 |
| Potassium;Period 2;Day 2, 24 Hours Post-dose | 4.269 ± 0.334 | 4.555 ± 0.402 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.
| Micromoles per liter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Creat; Period 1; Day -1, 24 Hours Pre-dose | 82.4 ± 15.29 | 83.4 ± 15.45 |
| Creat; Period 1; Day 2, 24 Hours Post-dose | 79.9 ± 12.00 | 85.9 ± 15.59 |
| Creat; Period 2; Day -1, 24 Hours Pre-dose | 81.1 ± 14.31 | 78.5 ± 14.21 |
| Creat; Period 2; Day 2, 24 Hours Post-dose | 83.9 ± 15.33 | 78.4 ± 12.71 |
| Total bil; Period1;Day -1, 24 Hours Pre-dose | 10.14 ± 4.633 | 10.99 ± 6.235 |
| Total bil; Period1;Day 2, 24 Hours Post-dose | 6.83 ± 3.004 | 8.10 ± 6.191 |
| Total bil; Period2;Day -1, 24 Hours Pre-dose | 9.90 ± 7.205 | 8.22 ± 3.516 |
| Total bil; Period2;Day 2, 24 Hours Post-dose | 6.47 ± 3.749 | 6.16 ± 2.843 |
| Direct bil; Period1;Day -1, 24 Hours Pre-dose | 3.68 ± 1.294 | 4.01 ± 1.794 |
| Direct bil; Period1;Day 2, 24 Hours Post-dose | 2.65 ± 0.959 | 2.93 ± 1.630 |
| Direct bil; Period2;Day -1, 24 Hours Pre-dose | 3.58 ± 1.945 | 3.12 ± 1.057 |
| Direct bil; Period2;Day 2, 24 Hours Post-dose | 2.55 ± 1.149 | 2.49 ± 0.972 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.
| Grams per liter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 74.34 ± 3.354 | 74.77 ± 4.725 |
| Period 1; Day 2, 24 Hours Post-dose | 67.90 ± 3.295 | 67.97 ± 2.635 |
| Period 2; Day -1, 24 Hours Pre-dose | 73.76 ± 3.995 | 72.57 ± 3.886 |
| Period 2; Day 2, 24 Hours Post-dose | 67.64 ± 3.181 | 67.89 ± 4.211 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.
| 10^9 cells per liter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Basophil; Period 1;Day -1, 24 Hours Pre-dose | 0.023 ± 0.017 | 0.022 ± 0.013 |
| Basophil; Period 1;Day 2, 24 Hours Post-dose | 0.024 ± 0.012 | 0.025 ± 0.011 |
| Basophil; Period 2;Day -1, 24 Hours Pre-dose | 0.026 ± 0.012 | 0.029 ± 0.025 |
| Basophil; Period 2;Day 2, 24 Hours Post-dose | 0.024 ± 0.012 | 0.022 ± 0.026 |
| Eosinophil; Period 1;Day-1, 24 Hours Pre-dose | 0.136 ± 0.130 | 0.182 ± 0.157 |
| Eosinophil; Period 1;Day 2, 24 Hours Post-dose | 0.146 ± 0.130 | 0.204 ± 0.199 |
| Eosinophil; Period 2; Day -1, 24 Hours Pre-dose | 0.231 ± 0.230 | 0.139 ± 0.144 |
| Eosinophil; Period 2; Day 2, 24 Hours Post-dose | 0.253 ± 0.245 | 0.156 ± 0.182 |
| Leucocyte; Period 1;Day-1,24 Hours Pre-dose | 5.458 ± 1.643 | 5.752 ± 0.907 |
| Leucocyte; Period 1;Day 2,24 Hours Post-dose | 5.369 ± 1.535 | 5.394 ± 1.019 |
| Leucocyte; Period 2;Day -1,24 Hours Pre-dose | 5.736 ± 1.168 | 5.463 ± 1.388 |
| Leucocyte; Period 2;Day 2,24 Hours Post-dose | 5.887 ± 1.216 | 5.477 ± 1.571 |
| Lymphocyte; Period 1;Day -1,24 Hours Pre-dose | 2.127 ± 0.562 | 2.154 ± 0.493 |
| Lymphocyte; Period 1;Day 2,24 Hours Post-dose | 1.916 ± 0.453 | 2.039 ± 0.459 |
| Lymphocyte; Period 2;Day -1,24 Hours Pre-dose | 2.328 ± 0.573 | 2.141 ± 0.409 |
| Lymphocyte; Period 2;Day 2,24 Hours Post-dose | 2.186 ± 0.431 | 1.956 ± 0.486 |
| Monocytes; Period 1;Day -1,24 Hours Pre-dose | 0.480 ± 0.123 | 0.470 ± 0.127 |
| Monocytes; Period 1;Day 2,24 Hours Post-dose | 0.464 ± 0.142 | 0.459 ± 0.125 |
| Monocytes; Period 2;Day -1,24 Hours Pre-dose | 0.461 ± 0.146 | 0.497 ± 0.126 |
| Monocytes; Period 2;Day 2,24 Hours Post-dose | 0.475 ± 0.160 | 0.457 ± 0.122 |
| Neutrophils;Period 1;Day -1,24 Hours Pre-dose | 2.692 ± 1.293 | 2.924 ± 0.706 |
| Neutrophils;Period 1;Day 2,24 Hours Post-dose | 2.820 ± 1.289 | 2.667 ± 0.667 |
| Neutrophils;Period 2;Day -1,24 Hours Pre-dose | 2.691 ± 0.697 | 2.657 ± 1.162 |
| Neutrophils;Period 2;Day 2,24 Hours Post-dose | 2.949 ± 0.848 | 2.885 ± 1.204 |
| Platelet; Period 1;Day -1,24 Hours Pre-dose | 288.9 ± 61.98 | 264.4 ± 60.63 |
| Platelet; Period 1;Day 2,24 Hours Post-dose | 281.2 ± 65.74 | 244.5 ± 64.60 |
| Platelet; Period 2;Day -1,24 Hours Pre-dose | 264.6 ± 61.65 | 289.6 ± 72.29 |
| Platelet; Period 2;Day 2,24 Hours Post-dose | 245.0 ± 56.04 | 274.2 ± 68.61 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.
| Femtoliter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 85.73 ± 2.834 | 84.86 ± 4.946 |
| Period 1; Day 2, 24 Hours Post-dose | 85.30 ± 2.796 | 84.50 ± 4.895 |
| Period 2; Day -1, 24 Hours Pre-dose | 84.83 ± 4.975 | 85.97 ± 2.903 |
| Period 2; Day 2, 24 Hours Post-dose | 84.46 ± 4.878 | 85.41 ± 2.847 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.
| Picogram | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 29.58 ± 1.212 | 29.44 ± 2.140 |
| Period 1; Day 2, 24 Hours Post-dose | 29.75 ± 1.295 | 29.51 ± 2.190 |
| Period 2; Day -1, 24 Hours Pre-dose | 29.40 ± 2.242 | 29.68 ± 1.207 |
| Period 2; Day 2, 24 Hours Post-dose | 29.54 ± 2.112 | 29.75 ± 1.320 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.
| 10^12 cells per liter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 5.104 ± 0.451 | 5.020 ± 0.480 |
| Period 1; Day 2, 24 Hours Post-dose | 4.952 ± 0.387 | 4.871 ± 0.424 |
| Period 2; Day -1, 24 Hours Pre-dose | 5.006 ± 0.366 | 4.971 ± 0.473 |
| Period 2; Day 2, 24 Hours Post-dose | 4.838 ± 0.433 | 4.906 ± 0.494 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.
| Proportion of red blood cells in blood | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 0.437 ± 0.036 | 0.426 ± 0.043 |
| Period 1; Day 2, 24 Hours Post-dose | 0.422 ± 0.033 | 0.411 ± 0.038 |
| Period 2; Day -1, 24 Hours Pre-dose | 0.424 ± 0.029 | 0.427 ± 0.040 |
| Period 2; Day 2, 24 Hours Post-dose | 0.408 ± 0.036 | 0.419 ± 0.041 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.
| Grams per deciliter | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| MCHC; Period 1; Day -1, 24 Hours Pre-dose | 34.52 ± 1.030 | 34.68 ± 0.957 |
| MCHC; Period 1; Day 2, 24 Hours Post-dose | 34.88 ± 1.084 | 34.89 ± 1.100 |
| MCHC; Period 2; Day -1, 24 Hours Pre-dose | 34.64 ± 1.100 | 34.54 ± 0.880 |
| MCHC; Period 2; Day 2, 24 Hours Post-dose | 34.95 ± 1.097 | 34.82 ± 1.062 |
| Hb; Period 1;Day -1, 24 Hours Pre-dose | 15.11 ± 1.554 | 14.79 ± 1.833 |
| Hb; Period 1;Day 2, 24 Hours Post-dose | 14.74 ± 1.391 | 14.38 ± 1.623 |
| Hb; Period 2;Day -1, 24 Hours Pre-dose | 14.70 ± 1.381 | 14.76 ± 1.591 |
| Hb; Period 2;Day 2, 24 Hours Post-dose | 14.29 ± 1.578 | 14.60 ± 1.708 |
Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.
| Percentage of reticulocytes | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day -1, 24 Hours Pre-dose | 1.786 ± 0.361 | 1.700 ± 0.346 |
| Period 1; Day 2, 24 Hours Post-dose | 1.757 ± 0.384 | 1.571 ± 0.297 |
| Period 2; Day -1, 24 Hours Pre-dose | 1.729 ± 0.397 | 1.886 ± 0.335 |
| Period 2; Day 2, 24 Hours Post-dose | 2.350 ± 2.176 | 1.743 ± 0.361 |
Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.
| Participants | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis | 0 | 0 |
Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
| Breaths per minute | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day 1, 1.5 Hours Pre-dose | 15.0 ± 1.11 | 15.7 ± 0.73 |
| Period 1; Day 1, 2 Hours Post-dose | 17.3 ± 2.02 | 17.0 ± 2.69 |
| Period 1; Day 1, 4 Hours Post-dose | 15.5 ± 2.10 | 14.2 ± 1.25 |
| Period 1; Day 1, 6 Hours Post-dose | 15.0 ± 2.00 | 14.8 ± 0.97 |
| Period 1; Day 2, 24 Hours Post-dose | 15.9 ± 2.14 | 16.1 ± 2.95 |
| Period 2; Day 1, 1.5 Hours Pre-dose | 15.8 ± 1.19 | 15.6 ± 0.74 |
| Period 2; Day 1, 2 Hours Post-dose | 18.4 ± 1.65 | 18.2 ± 1.72 |
| Period 2; Day 1, 4 Hours Post-dose | 16.7 ± 3.10 | 18.4 ± 1.65 |
| Period 2; Day 1, 6 Hours Post-dose | 17.9 ± 1.46 | 19.0 ± 1.04 |
| Period 2; Day 2, 24 Hours Post-dose | 16.2 ± 1.25 | 16.0 ± 2.22 |
Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
| Beats per minute | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day 1, 1.5 Hours Pre-dose | 67.0 ± 7.95 | 58.1 ± 8.76 |
| Period 1; Day 1, 2 Hours Post-dose | 61.0 ± 8.17 | 55.1 ± 8.32 |
| Period 1; Day 1, 4 Hours Post-dose | 61.9 ± 7.44 | 55.6 ± 7.49 |
| Period 1; Day 1, 6 Hours Post-dose | 75.0 ± 8.74 | 67.2 ± 12.97 |
| Period 1; Day 2, 24 Hours Post-dose | 66.5 ± 10.26 | 54.3 ± 7.22 |
| Period 2; Day 1, 1.5 Hours Pre-dose | 57.9 ± 9.08 | 65.1 ± 6.85 |
| Period 2; Day 1, 2 Hours Post-dose | 54.1 ± 8.88 | 63.1 ± 8.87 |
| Period 2; Day 1, 4 Hours Post-dose | 56.6 ± 8.67 | 62.8 ± 7.92 |
| Period 2; Day 1, 6 Hours Post-dose | 68.5 ± 14.09 | 75.1 ± 8.82 |
| Period 2; Day 2, 24 Hours Post-dose | 59.2 ± 7.59 | 67.1 ± 8.62 |
Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
| Degree Celsius | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| Period 1; Day 1, 1.5 Hours Pre-dose | 36.19 ± 0.305 | 36.27 ± 0.336 |
| Period 1; Day 1, 2 Hours Post-dose | 36.38 ± 0.333 | 36.23 ± 0.261 |
| Period 1; Day 1, 4 Hours Post-dose | 36.48 ± 0.336 | 36.59 ± 0.352 |
| Period 1; Day 1, 6 Hours Post-dose | 36.64 ± 0.303 | 36.79 ± 0.202 |
| Period 1; Day 2, 24 Hours Post-dose | 36.29 ± 0.317 | 36.24 ± 0.365 |
| Period 2; Day 1, 1.5 Hours Pre-dose | 36.28 ± 0.372 | 36.29 ± 0.317 |
| Period 2; Day 1, 2 Hours Post-dose | 36.51 ± 0.400 | 36.42 ± 0.404 |
| Period 2; Day 1, 4 Hours Post-dose | 36.58 ± 0.347 | 36.51 ± 0.243 |
| Period 2; Day 1, 6 Hours Post-dose | 36.10 ± 0.421 | 36.63 ± 0.300 |
| Period 2; Day 2, 24 Hours Post-dose | 36.30 ± 0.321 | 36.11 ± 0.434 |
Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
| Millimeters of mercury | SKF101804 Cefixime | Cefixime Reference Formulation |
|---|---|---|
| SBP, Period 1; Day 1, 1.5 Hours Pre-dose | 110.6 ± 8.22 | 110.9 ± 6.39 |
| SBP, Period 1; Day 1, 2 Hours Post-dose | 113.4 ± 7.30 | 111.3 ± 8.68 |
| SBP, Period 1; Day 1, 4 Hours Post-dose | 112.3 ± 8.39 | 112.1 ± 4.25 |
| SBP, Period 1; Day 1, 6 Hours Post-dose | 111.6 ± 7.17 | 108.6 ± 6.46 |
| SBP, Period 1; Day 2, 24 Hours Post-dose | 110.9 ± 6.86 | 115.4 ± 7.00 |
| SBP, Period 2; Day 1, 1.5 Hours Pre-dose | 110.4 ± 3.97 | 111.2 ± 10.09 |
| SBP, Period 2; Day 1, 2 Hours Post-dose | 113.1 ± 6.24 | 112.7 ± 10.94 |
| SBP, Period 2; Day 1, 4 Hours Post-dose | 112.6 ± 8.53 | 111.1 ± 9.79 |
| SBP, Period 2; Day 1, 6 Hours Post-dose | 109.6 ± 7.14 | 109.5 ± 8.98 |
| SBP, Period 2; Day 2, 24 Hours Post-dose | 113.1 ± 6.24 | 113.6 ± 9.05 |
| DBP, Period 1; Day 1, 1.5 Hours Pre-dose | 62.9 ± 6.59 | 64.1 ± 7.76 |
| DBP, Period 1; Day 1, 2 Hours Post-dose | 62.9 ± 7.69 | 60.9 ± 6.38 |
| DBP, Period 1; Day 1, 4 Hours Post-dose | 62.5 ± 5.43 | 63.3 ± 6.94 |
| DBP, Period 1; Day 1, 6 Hours Post-dose | 59.3 ± 3.89 | 59.6 ± 5.09 |
| DBP, Period 1; Day 2, 24 Hours Post-dose | 63.0 ± 6.80 | 66.2 ± 7.65 |
| DBP, Period 2; Day 1, 1.5 Hours Pre-dose | 111.2 ± 10.09 | 61.8 ± 7.20 |
| DBP, Period 2; Day 1, 2 Hours Post-dose | 66.2 ± 7.65 | 63.1 ± 9.12 |
| DBP, Period 2; Day 1, 4 Hours Post-dose | 63.5 ± 8.55 | 62.6 ± 8.21 |
| DBP, Period 2; Day 1, 6 Hours Post-dose | 59.4 ± 4.97 | 60.2 ± 7.79 |
| DBP, Period 2; Day 2, 24 Hours Post-dose | 63.9 ± 7.41 | 67.7 ± 7.90 |
Collected over Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to Day 16 in each treatment period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SKF101804 Cefixime | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Cefixime Reference Formulation | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 28.9 ± 7.90 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 7 |
| Male | 21 |
| Race/Ethnicity, Customized(Participants) | All Participants |
|---|---|
| Mixed Race | 3 |
| White/Caucasian/European Heritage | 4 |
| Black or African American | 21 |
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, 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 Feb 2018 to primary completion in Mar 2018, 1 month.
Results were first posted in Mar 2019, 1 year after primary completion.
Of 52 industry-sponsored phase 1 interventional studies under Bacterial Infections, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 1 month is below that.
Counting every sponsor, half of 67 studies reached it within 9 months; a quarter within 4 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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