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Topiramate 25 mg Tablets Under Fasting Conditions

This study has been completed.
Information provided by:
Teva Pharmaceuticals USA Identifier:
First received: May 18, 2009
Last updated: August 14, 2009
Last verified: August 2009
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fasting conditions.

Condition Intervention Phase
Drug: Topiramate Tablets
Drug: Topamax® Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Tablets and Topamax® 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 96 hour period ]
  • AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant) [ Time Frame: Blood samples collected over 96 hour period ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 96 hour period ]

Enrollment: 30
Study Start Date: June 2001
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topiramate Tablets, 25 mg
Drug: Topiramate Tablets
Active Comparator: 2
Topamax® Tablets, 25 mg
Drug: Topamax® Tablets

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects will be females and/or males, non-smokers, 18 years of age or older
  • Subjects should read, sign and date an Informed Consent Form prior to any study procedures.
  • Female subjects will be post-menopausal or surgically sterilized.
  • Post menopausal status is defined as absence of menses for the past 12 months or bilateral oophorectomy at least 6 months ago or hysterectomy with bilateral oophorectomy at least 6 months ago.
  • Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation aat least 6 months ago.

Exclusion Criteria:

  • Clinically significant illnesses within 4 weeks of the administration of study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any history or presence of significant neurological, hepatic, renal, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
  • Any clinically significant abnormality found during medical screening.
  • Abnormal laboratory tests judged clinically significant.
  • Positive urine drug screen at screening.
  • Positive alcohol breath test at screening.
  • Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence is required.
  • Positive testing for hepatitis B, hepatitis C or HIV at screening.
  • ECG or vital sign abnormalities (clinically significant).
  • Subjects with BMI greater than or equal to 30.0.
  • History of significant alcohol abuse within 6 months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subjects participation in this study.
  • History of allergic reactions to topiramate.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism, use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
  • Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.

Additional exclusion criteria for females only:

• Positive urine pregnancy test at screening (performed on all females).

  Contacts and Locations
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Please refer to this study by its identifier: NCT00905606

Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Principal Investigator: Benoit Girard, MD Anapharm
  More Information Identifier: NCT00905606     History of Changes
Other Study ID Numbers: 01179
Study First Received: May 18, 2009
Results First Received: May 28, 2009
Last Updated: August 14, 2009

Keywords provided by Teva Pharmaceuticals USA:
Healthy Subjects

Additional relevant MeSH terms:
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents processed this record on April 28, 2017