NCT00649467CompletedPhase 1
Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mylan Pharmaceuticals Inc
- Enrollment
- 35
- Locations
- 1
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Topiramate Sprinkle Capsules 25 mg
Intervention: Topiramate Sprinkle Capsules 25 mg (Drug)
2
Active Comparator
Topamax® Sprinkle Capsules 25 mg
Intervention: Topamax® Sprinkle Capsules 25 mg (Drug)
Outcomes
Primary Outcomes
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 144 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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