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

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00649740
First received: March 30, 2008
Last updated: November 23, 2009
Last verified: November 2009

March 30, 2008
November 23, 2009
November 2005
December 2005   (final data collection date for primary outcome measure)
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 ]
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00649740 on ClinicalTrials.gov Archive Site
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Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Topiramate Sprinkle Capsules 25 mg
    25mg, single dose fasting
  • Drug: Topamax® Sprinkle Capsule 25 mg
    25mg, single dose fasting
  • Experimental: 1
    Topiramate Sprinkle Capsules 25 mg
    Intervention: Drug: Topiramate Sprinkle Capsules 25 mg
  • Active Comparator: 2
    Topamax® Sprinkle Capsule 25 mg
    Intervention: Drug: Topamax® Sprinkle Capsule 25 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00649740
TOPR-0583
Not Provided
Wayne Talton, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
Mylan Pharmaceuticals
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP