NCT03319706

Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablets Under Fed 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-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 Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi 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 Fed 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: 2010-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2017-10-24
• Last updated: 2017-10-24