Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg

Single-Dose Fasting 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

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 fasting conditions.

Inclusion Criteria:

• healthy, adult subjects, 18 years and older
• able to swallow medication

Exclusion Criteria:

• institutionalized subjects
• history of any significant disease
• use of any prescription or OTC medications within 14 days of start of study
• received any investigational products within 30 days prior to start of study