Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: tablet containing 25 mg of topiramate (Torrent Pharmaceuticals) arm 2: tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)

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

Protocol document: