NCT02962258

BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets	oral, crossover
DRUG	Tribenzor of Daichi Sankyo Inc. USA	oral, crossover

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2016-11-11
• Last updated: 2016-11-11