Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
Overview
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 fed conditions.
Full Title of Study: “Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2005
Interventions
- Drug: Olmesartan Medoxomil Tablets 40 mg
- 40mg, single dose fed
- Drug: Benicar® Tablets 40 mg
- 40mg, single dose fed
Arms, Groups and Cohorts
- Experimental: 1
- Olmesartan Medoxomil Tablets 40 mg
- Active Comparator: 2
- Benicar® Tablets 40 mg
Clinical Trial Outcome Measures
Primary Measures
- 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.
- Time Frame: blood collections through 48 hours
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Provider of Information About this Clinical Study
- Wayne Talton, Mylan Inc.
- Overall Official(s)
- James D Carlson, Pharm. D., Principal Investigator, PRACS Institute Ltd.
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