Paxil CR Bioequivalence Study Brazil - Fed Administration

Launched by GLAXOSMITHKLINE · Mar 24, 2011

Keywords

ClinConnect Summary

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 (tw...

Gender

ALL

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.