Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Single-Dose Fed Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers

ID
Name
TOPR-0584
Description
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.
Trial arms
Trial start
2005-11-01
Estimated PCD
2005-12-01
Trial end
2005-12-01
Status
Completed
Phase
Early phase I
Treatment
Topiramate Sprinkle Capsules 25 mg
25mg, single dose fed
Arms:
1
Topamax® Sprinkle Capsules 25 mg
25mg, 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 144 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
Topiramate
Indication
Healthy
Product
Topamax
Organization
Mylan Pharmaceuticals