Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
Sponsor
Mylan Pharmaceuticals Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00648219
Collaborator
(none)
36
1
2
1
35.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Dec 1, 2005
Actual Study Completion Date
:
Jan 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Olmesartan Medoxomil Tablets 40 mg |
Drug: Olmesartan Medoxomil Tablets 40 mg
40mg, single dose fed
|
| Active Comparator: 2 Benicar® Tablets 40 mg |
Drug: Benicar® Tablets 40 mg
40mg, single dose fed
|
Outcome Measures
Primary Outcome 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. [blood collections through 48 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRACS Institute, Ltd. | Fargo | North Dakota | United States | 58104 |
Sponsors and Collaborators
- Mylan Pharmaceuticals Inc
Investigators
- Principal Investigator: James D Carlson, Pharm. D., PRACS Institute Ltd.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Mylan Pharmaceuticals Inc. - Clinical Trial Results
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
- Recalls, Market Withdrawals and Safety Alerts
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00648219
Other Study ID Numbers:
- OLME-0575
First Posted:
Apr 1, 2008
Last Update Posted:
Nov 25, 2009
Last Verified:
Nov 1, 2009