Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00649467
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Topiramate Sprinkle Capsules 25 mg Topiramate Sprinkle Capsules 25 mg 2 Topamax® Sprinkle Capsules 25 mg Topamax® Sprinkle Capsules 25 mg
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kendle International Inc.
🇺🇸Morgantown, West Virginia, United States