CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Topiramatedrug
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.

Search/NCT00939692
NCT00939692Phase 1Completed
CompareCT.gov

Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Topiramate (2 x 25 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Topamax®, Ortho-McNeil Neurologics, Inc.)in Fasted, Healthy, Adult Subjects

Torrent Pharmaceuticals Limited·interventional·Posted Jul 15, 2009·Updated Jul 16, 2013

In Brief

A Phase 1 clinical trial evaluating Topiramate for Healthy. Completed, enrolled 26 participants across 1 site.

Detailed Summary

* Objective: * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions. * Clinical Design: * Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 15, 2009
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2007
Study CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago

Interventions

Topiramatedrug

Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate