NCT03318354

Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablet Under Fasting Conditions

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

• 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 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.

Detailed description

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan Medoxomil Tablets containing Olmesartan Medoxomil 40 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Benicar® 40 mg Tablets containing Olmesartan Medoxomil 40 mg (Reference, Daiichi Sankyo Inc.,USA) in Healthy Human Volunteers Under Fasting Condition.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Torrent's Olmesartan Medoxomil Tablets 40 mg
DRUG	Daiichi Sankyo Inc's Benicar Tablets 40 mg

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2017-10-23
• Last updated: 2017-10-23