Paxil CR Bioequivalence Study Brazil

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder

Treatments: Drug: Reference formulation; Drug: Test formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01316926

113939

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Paxil CR Reference

Active Comparator group

Description:

Reference drug administration followed by test drug administration

Treatment:

Drug: Reference formulation

Drug: Test formulation

Paxil CR Test

Active Comparator group

Description:

Test drug administration followed by Reference drug administration

Treatment:

Drug: Reference formulation

Drug: Test formulation