At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Topiramate Tablets +1 moredrug
Likely dose
Not stated in 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 Tablets and Topamax® 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Topiramate Tablets and Topamax® Tablets for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2001
Primary CompletionJun 2001
First PostedMay 2009
TodayJul 2026
First PostedMay 20, 2009
Enrollment StartJun 1, 2001
Primary CompletionJun 1, 2001
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.1 years ago
Interventions
Topiramate Tabletsdrug
Topamax® Tabletsdrug