CompletedNCT01316926Updated Jun 20, 2018Results posted

Paxil CR Bioequivalence Study Brazil

A Phase 1 interventional study of Test formulation and Reference formulation in Depressive Disorder, sponsored by GlaxoSmithKline. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-20.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Sep 2009, registered Aug 2010).

Phase: Phase 1
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).

Read the detailed description

Full title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fasted administration in healthy volunteers for both genders.

The study is open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration).

The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are not restrictions regarding the ethnic group.The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of concentration of drug in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each fasting period. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.

Conditions studied

Depressive Disorder

Browse trials for

Depressive Disorder 4,845

Keywords

fast condition
Paroxetine reference/test
healthy volunteers
Bioequivalence

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

EXCLUSION CRITERIA:

hypersensitivity to the study drug or to compounds chemically related;
history of serious adverse events;
concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
History of liver, heart, gastrointestinal or renal illness;
ECG findings not recommended according to the investigator judgement;
The volunteer ingests more than 5 cups of coffee or tea a day.

INCLUSION CRITERIA:

Man and woman (since they are not pregnant or breastfeeding);
age between 18 and 40 years;
non-smoker and not addict;
mass index between 18,5 and 27;
good health conditions or without significant illness, by judgement of a legally qualified professional;
sign the informed consent.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

Active comparator
Paxil CR Reference
Reference drug administration followed by test drug administration
Drug: Test formulation · Drug: Reference formulation
Active comparator
Paxil CR Test
Test drug administration followed by Reference drug administration
Drug: Test formulation · Drug: Reference formulation

Interventions

DrugTest formulation
Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
DrugReference formulation
Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

What researchers measure

Primary outcomes

Area Under the Curve_steady-state
The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_steady-state (ss) is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.
Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Cmin_steady-state
Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.
Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Cmax_steady-state
Cmax_steady-state (ss) is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.
Time frame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)

Results

Posted Apr 18, 2011

Limitations and caveats

The number of adverse events per intervention is not available in the final report.

Participant flow

Recruitment is conducted in accordance with internal Standard Operating Procedures of the research center and with the consent of the participants (Term of Recruitment and Informed Consent Form).

Period 1

Participant flow — Period 1
Milestone	Test Product in Period 1; Reference Product in Period 2	Reference Product in Period 1; Test Product in Period 2
Started	30	30
Completed	30	30
Not completed	0	0

Period 2

Participant flow — Period 2
Milestone	Test Product in Period 1; Reference Product in Period 2	Reference Product in Period 1; Test Product in Period 2
Started	29	30
Completed	29	30
Not completed	0	0

Outcome measures

PrimaryArea Under the Curve_steady-state

The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_steady-state (ss) is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.

Time frame:: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Reported as:: Mean · ng/h/ml

Area Under the Curve_steady-state
ng/h/ml	Test Product	Reference Product
Area Under the Curve_steady-state	996.2436 ± 546.1831	1038.5812 ± 550.8923

Statistical analysis

Test Product vs Reference Product · Ratio t formulation/r formulation: 0.9204 · 90% CI 0.8556 to 0.9900Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.

PrimaryCmin_steady-state

Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.

Time frame:: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Reported as:: Mean · ng/ml

Cmin_steady-state
ng/ml	Test Product	Reference Product
Cmin_steady-state	26.4410 ± 15.7817	27.9625 ± 15.8840

Statistical analysis

Test Product vs Reference Product · Ratio t formulation/r formulation: 0.9410 · 90% CI 0.8460 to 1.0467Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.

PrimaryCmax_steady-state

Cmax_steady-state (ss) is defined as the maximum or "peak" concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.

Time frame:: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Reported as:: Mean · ng/ml

Cmax_steady-state
ng/ml	Test Product	Reference Product
Cmax_steady-state	61.0319 ± 34.8551	64.3281 ± 35.7439

Statistical analysis

Test Product vs Reference Product · Ratio t formulation/r formulation: 0.9333 · 90% CI 0.8502 to 1.0246Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Period 1	—	0/60 (0%)	42/60 (70%)
Period 2	—	0/59 (0%)	13/59 (22%)

Most frequent other events

Showing 10 of 28

Most frequent other events
Event	Period 1	Period 2
NauseaGastrointestinal disorders	19/60	1/59
SomnolenceNervous system disorders	16/60	1/59
CephaleaGeneral disorders	13/60	4/59
XerostomiaGastrointestinal disorders	4/60	0/59
DiarrheaGastrointestinal disorders	3/60	0/59
TonsillitisInfections and infestations	0/60	2/59
HeartburnGastrointestinal disorders	2/60	1/59
Stomach-acheGastrointestinal disorders	2/60	0/59
Sore throatGastrointestinal disorders	2/60	0/59
InsomniaNervous system disorders	2/60	1/59

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Participants Receiving Both Test and Reference Product
Mean	28.85 ± 4.91

Sex: Female, Male
Sex: Female, Male(Participants)	Participants Receiving Both Test and Reference Product
Female	30
Male	30

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Participants Receiving Both Test and Reference Product
Caucasian	37
Black	4
Mixed Race	19

Study locations

1 site

GSK Investigational Site
Belo Horizonte, Minas Gerais 30110-014, Brazil

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01316926
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Mar 16, 2011
Start date: Sep 9, 2009
Primary completion: Oct 5, 2009
Completion: Oct 5, 2009
Results posted: Apr 18, 2011
Last update: Jun 20, 2018

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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