This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 ]
Bioequivalence [ Time Frame: within 30 days ]
Complete list of historical versions of study NCT00649740 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00649740
TOPR-0583
Not Provided
Not Provided
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