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Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
This study has been completed.
First Received: March 30, 2008   Last Updated: November 23, 2009   History of Changes
Sponsor: Mylan Pharmaceuticals
Information provided by: Mylan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00649467
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Topiramate Sprinkle Capsules 25 mg
Drug: Topamax® Sprinkle Capsules 25 mg
Phase I

Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [ Time Frame: blood collections through 144 hours ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: November 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Topiramate Sprinkle Capsules 25 mg
Drug: Topiramate Sprinkle Capsules 25 mg
25mg, single dose applesauce
2: Active Comparator
Topamax® Sprinkle Capsules 25 mg
Drug: Topamax® Sprinkle Capsules 25 mg
25mg, single dose applesauce

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649467

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Mylan Inc. ( Wayne Talton )
Study ID Numbers: TOPR-0585
Study First Received: March 30, 2008
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00649467     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Topiramate
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010