ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00649623
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Mylan Pharmaceuticals

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 fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Olmesartan Medoxomil Tablets 40 mg Drug: Benicar® Tablets 40 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers
Study Start Date : December 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Olmesartan Medoxomil Tablets 40 mg
Drug: Olmesartan Medoxomil Tablets 40 mg
40mg, single dose fasting

Active Comparator: 2
Benicar® Tablets 40 mg
Drug: Benicar® Tablets 40 mg
40mg, single dose fasting




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649623


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.

Additional Information:
Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00649623     History of Changes
Other Study ID Numbers: OLME-0574
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action