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
  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:


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:
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 April 17, 2014