Clinical trial NCT01316926: Paxil CR Bioequivalence Study Brazil
Official title: Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablet With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fasted Administration in Healthy Volunteers for Both Genders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder
Keywords: fast condition
Paroxetine reference/test
healthy volunteers
Bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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).

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.

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.

Primary outcomes:
measure: Area Under the Curve_steady-state
timeFrame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
measure: Cmin_steady-state
timeFrame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
measure: Cmax_steady-state
timeFrame: Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
state: Minas Gerais
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: