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An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesaartan Medoxomil, Amlopdipine and Hydrochlorothiazide (40+10+25) mg Tab [Torrent,India] Vs Tribenzor(40+10+25) mg Tab [ Daichi Sankyo, Inc USA] in Healthy Subjects-Fasted Condition.
Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.
Details
| Lead sponsor | Torrent Pharmaceuticals Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 34 |
| Start date | 2011-05 |
| Completion | 2011-06 |
Conditions
- Healthy Subjects
Interventions
- Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets
- Tribenzor Tablets of Daichi Sankyo Inc, USA
Primary outcomes
- Cmax — Pre-dose to 72 hours after post dose
- AUC — Pre-dose to 72 hours after post dose