Single-Dose Fed Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers

NCT01019590 Phase 1 COMPLETED

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under fed conditions.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2006-11
Completion	2006-11

Conditions

• Healthy

Interventions

• Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
• Benicar HCT ® Tablets 40 mg/25 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