Last reviewed · How we verify
An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Fluoxetine Tablets 20 mg [Torrent,India] Versus Sarafem 20 mg Tablet [ Warner Chilcott LLC, USA] in Healthy Subjects-Fed Condition.
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
Details
| Lead sponsor | Torrent Pharmaceuticals Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2013-11 |
| Completion | 2014-01 |
Conditions
- Healthy Subjects
Interventions
- Torrent's Fluoxetine Tablets
- Warner Chilcott LLC's Sarafem Tablet
Primary outcomes
- Cmax — pre-dose to 72 hours post-dose
- AUC — pre-dose to 72 hours post-dose