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-Fasted Condition

NCT03318354 Phase 1 COMPLETED

Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets 40 mg and Benicar 40 mg Tablets of Daichi 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	2010-05
Completion	2010-07

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.