Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mylan Pharmaceuticals
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• healthy, adult subjects, 18 years and older

• able to swallow medication

Exclusion Criteria:

• institutionalized subjects

• history of any significant disease

• use of any prescription or OTC medications within 14 days of start of study

• received any investigational products within 30 days prior to start of study