Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg (Drug); Benicar HCT® Tablets 40 mg/25 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s): Alan K Copa, Pharm. D., Principal Investigator, Affiliation: PRACS Institute Ltd.
Summary
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan
medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg
tablets following a single, oral 40 mg/25 mg (1 x 40 mg/25 mg) dose administered under
fasting conditions.
Clinical Details
Official title: Single-Dose Fasting Bioequivalence Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets (40 mg/25 mg; Mylan) to Benicar HCT® Tablets (40 mg/25 mg; Sankyo) in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
PRACS Institute Ltd., Fargo, North Dakota 58104, United States
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 FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: November 2006
Last updated: November 23, 2009
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