CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Topiramate 2 x 25 mg tablet +1 moredrug
Likely dose
Topiramate 2 x 25 mg tabletfrom 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.

Search/NCT00905567
NCT00905567Phase 1Completed
CompareCT.gov

Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fed Conditions

Teva Pharmaceuticals USA·interventional·Posted May 20, 2009·Updated Sep 23, 2009

In Brief

A Phase 1 clinical trial evaluating Topiramate 2 x 25 mg tablet and Topamax® Tablet 2 x 25 mg 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 of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
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 2 x 25 mg tabletdrug

Topamax® Tablet 2 x 25 mgdrug