Trials / Completed
CompletedNCT00648219
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Mylan Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olmesartan Medoxomil Tablets 40 mg | 40mg, single dose fed |
| DRUG | Benicar® Tablets 40 mg | 40mg, single dose fed |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2005-12-01
- Completion
- 2006-01-01
- First posted
- 2008-04-01
- Last updated
- 2024-04-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00648219. Inclusion in this directory is not an endorsement.