Paxil CR Bioequivalence Study Brazil - Fed Administration
Depressive Disorder
About this trial
This is an interventional other trial for Depressive Disorder focused on measuring Bioequivalence, Paroxetine reference/test, healthy volunteers, Fed condition
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Paxil CR Reference
Paxil CR Test
Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 1, followed by Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 2
Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada, in Period 1, followed by Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico, in Period 2