Clinical trial NCT01339247
Conditions: Depressive Disorder
Keywords: Bioequivalence Paroxetine reference/test healthy volunteers Fed condition
Sponsor: GlaxoSmithKline
Start date: 2009-10-20; Completion date: 2009-11-16
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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

Detailed description:
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), fed administration in healthy volunteers of both genders.

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). 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 no 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 drug concentration 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 period after standardized meals. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.

Arms: arm 1: Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 2 arm 2: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 1, followed by Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 2
Interventions: intervention 1: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico intervention 2: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
Intervention descriptions: intervention 1: Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation) intervention 2: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)

Protocol documents: