Paxil CR Bioequivalence Study Brazil - Fed Administration

• Status: Completed
• Trial end date: 2009-11-16
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Halofantrine; Paroxetine

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.