Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01019590
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Brief 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 fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Benicar HCT ® Tablets 40 mg/25 mg Benicar HCT ® Tablets 40 mg/25 mg 1 Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRACS Institute Ltd.
🇺🇸Fargo, North Dakota, United States