Overview

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