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Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648219
First received: March 30, 2008
Last updated: November 23, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Olmesartan Medoxomil Tablets 40 mg
Drug: Benicar® Tablets 40 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

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. [ Time Frame: blood collections through 48 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2005
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648219

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute Ltd.
  More Information

Additional Information:
Mylan Pharmaceuticals Inc. - Clinical Trial Results  This link exits the ClinicalTrials.gov site
Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use  This link exits the ClinicalTrials.gov site
Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
FDA Enforcement Report Index  This link exits the ClinicalTrials.gov site
Medwatch, FDA Safety Information and Adverse Event Reporting Program  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00648219     History of Changes
Other Study ID Numbers: OLME-0575
Study First Received: March 30, 2008
Last Updated: November 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Olmesartan medoxomil
Olmesartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013