Overview

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

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mylan Pharmaceuticals
Treatments:
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Criteria
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