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Paxil CR Bioequivalence Study Brazil

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder; Healthy Volunteers

Intervention: Test formulation (Drug); Reference formulation (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Area Under the Curve_steady-state

Cmin_steady-state

Cmax_steady-state

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

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.

Locations and Contacts

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

Starting date: September 2009
Last updated: April 28, 2011

Page last updated: August 23, 2015

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