Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg - Full Text View

Sponsor:	Mylan Pharmaceuticals
Information provided by:	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00649623

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 fasting conditions.

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

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:

Drug Information available for: Olmesartan Olmesartan medoxomil

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:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Olmesartan Medoxomil Tablets 40 mg	Drug: Olmesartan Medoxomil Tablets 40 mg 40mg, single dose fasting
2: Active Comparator Benicar® Tablets 40 mg	Drug: Benicar® Tablets 40 mg 40mg, single dose fasting

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: 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.

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:	Mylan Inc. ( Wayne Talton )
Study ID Numbers:	OLME-0574
Study First Received:	March 30, 2008
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00649623 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Olmesartan medoxomil

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010