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 Fed, Healthy, Adult Subjects
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 adult subjects under fed conditions.
- Clinical Design:
- Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.
Study Design
N/A
Conditions
Healthy
Intervention
topiramate
Location
Gateway Medical Research, Inc.
St, Charles
Missouri
United States
Status
Completed
Source
Torrent Pharmaceuticals Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00939705
- Information obtained from ClinicalTrials.gov on July 15, 2010
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