NCT00649623

Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Olmesartan Medoxomil Tablets 40 mg	40mg, single dose fasting
DRUG	Benicar® Tablets 40 mg	40mg, single dose fasting

Timeline

• Start date: 2005-12-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States