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Clinical trial

Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers

ID
Name
OLME-0575
Description
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.
Trial arms
Trial start
2005-12-01
Estimated PCD
2005-12-01
Trial end
2006-01-01
Status
Completed
Phase
Early phase I
Treatment
Olmesartan Medoxomil Tablets 40 mg
40mg, single dose fed
Arms:
1
Benicar® Tablets 40 mg
40mg, single dose fed
Arms:
2
Size
36
Primary endpoint
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.
blood collections through 48 hours
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2024-04-23

1 organization

2 products

1 indication

Product
Olmesartan Medoxomil
Indication
Healthy
Product
Benicar
Organization
Mylan Pharmaceuticals