Paxil CR Bioequivalence Study Brazil

• Status: Completed
• Trial end date: 2009-10-05
• 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 drug test and reference (two periods of drug administration).

• 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.