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

NCT00649623 Phase 1 COMPLETED

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.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2005-12
Completion	2005-12

Conditions

• Healthy

Interventions

• Olmesartan Medoxomil Tablets 40 mg
• Benicar® Tablets 40 mg

Primary outcomes

• The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. — blood collections through 48 hours

Countries

United States