An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of FDC of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab 40+10+25 mg [Torrent,India] Vs Tribenzor 40+10+25 mg Tablets [ Daichi,USA] in Healthy Subjects-Fed Condition.

NCT02962258 Phase 1 COMPLETED

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 Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets
• Tribenzor 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