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Paxil CR Bioequivalence Study Brazil - Fed Administration

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: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (Drug); Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (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 test drug and the reference drug (two periods of drug administration after standardized meals).

Clinical Details

Official title: Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablets With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fed Administration in Healthy Volunteers of Both Genders

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

Primary outcome:

AUC_ss

Cmin_ss

Cmax_ss

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.

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: October 2009
Last updated: May 5, 2011

Page last updated: August 23, 2015

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