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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00649467
First Posted: April 1, 2008
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mylan Pharmaceuticals
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 ]

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
Experimental: 1
Topiramate Sprinkle Capsules 25 mg
Drug: Topiramate Sprinkle Capsules 25 mg
25mg, single dose applesauce
Active Comparator: 2
Topamax® Sprinkle Capsules 25 mg
Drug: Topamax® Sprinkle Capsules 25 mg
25mg, single dose applesauce

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00649467     History of Changes
Other Study ID Numbers: TOPR-0585
First Submitted: March 30, 2008
First Posted: April 1, 2008
Last Update Posted: November 25, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents