NCT02962336

Bioequivalence Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochloride Tablets Under Fasting Conditions.

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.

• 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 FDC of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg 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 Fasting Condition.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets	Oral, crossover
DRUG	Tribenzor Tablets 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