NCT00905164

Topiramate 25 mg Capsules Under Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Capsules and Topamax® 25 mg Sprinkle Capsules Administered as 2 x 25 mg Capsules in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg capsules (test) versus Topamax® (reference) administered as 2 x 25 mg capsules under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Topiramate Capsules, 25 mg	Topiramate Capsules, 2 x 25 mg
DRUG	Topamax® Capsules, 25 mg	Topamax® Capsules, 2 x 25 mg

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2009-05-20
• Last updated: 2024-09-19
• Results posted: 2009-09-23

Locations

1 site across 1 country: Canada