Status:
COMPLETED
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 2...
Eligibility Criteria
Inclusion
- healthy, adult subjects, 18 years and older
- able to swallow medication
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00648934
Start Date
November 1 2005
End Date
December 1 2005
Last Update
April 23 2024
Active Locations (1)
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1
Kendle International Inc.
Morgantown, West Virginia, United States, 26505