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

Completed · Phase 1

Conditions studied: Healthy

In brief

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 administered under fasting conditions.

Key facts

Study ID

NCT00649740

Run by

Mylan Pharmaceuticals Inc

People needed

36

Starts

2005-11-01

Expected to finish

2005-12-01

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy, adult subjects, 18 years and older
• able to swallow medication

You may not qualify if…

• 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

Where it is running

• Kendle International Inc. — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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