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An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Olmesartan Medoxomil Tablets 40 mg [Torrent,India] Versus Benicar 40 mg Tablets [Daiichi Sankyo Inc., USA] in Healthy Subjects-Fed Condition.
Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were separated by a washout period of 7 days.
Details
| Lead sponsor | Torrent Pharmaceuticals Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 34 |
| Start date | 2010-08 |
| Completion | 2010-09 |
Conditions
- Healthy Subjects
Interventions
- Torrent's Olmesartan Medoxomil Tablets 40 mg
- Daiichi Sankyo Inc's Benicar Tablets 40 mg
Primary outcomes
- Cmax — pre-dose to 72 hours post dose
- AUC — pre-dose to 72 hours post dose