At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Topiramate 25 mg Capsules +2 moredrug
Likely dose
Topiramate 25 mg Capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Capsules and Topamax® 25 mg Capsules Administered as the Content of 2 x 25 mg Capsules Mixed With Applesauce in Healthy Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Topiramate 25 mg Capsules, Topamax® 25 mg Capsules, and 1 other intervention for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The objective of this study was to compare the rate and extent of absorption or topiramate 25 mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg capsules mixed with applesauce under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2002
Primary CompletionJul 2002
First PostedMay 2009
TodayJul 2026
First PostedMay 20, 2009
Enrollment StartJun 1, 2002
Primary CompletionJul 1, 2002
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago
Interventions
Topiramate 25 mg Capsulesdrug
Topiramate Capsules 2 x 25 mg
Topamax® 25 mg Capsulesdrug
Topamax® Capsule 2 x 25 mg
Applesauceother
Applesauce