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Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00901784
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : June 18, 2009
Information provided by:

Study Description
Brief Summary:
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions.

Condition or disease Intervention/treatment
Healthy Drug: Topiramate

Detailed Description:
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 4 alternates. All 28 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Subjects were to return for the 48-, 72-, 96- and 120-hour blood draws. Both periods were separated by a washout period of 14 days.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Comparative, Randomized, Single Dose, 2-Way Crossover Relative Bioavailability Study of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg Topiramate Tablets Following a 50 mg Dose in Healthy Adult Males Under Fasting Conditions
Study Start Date : September 2001
Primary Completion Date : September 2001
Study Completion Date : October 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
25 mg Topiramate tablets of Ranbaxy Laboratories, Ltd
Drug: Topiramate
25mg Tablets
Active Comparator: 2
(Topamax®) 25 mg Topiramate tablets of Ortho-McNeil Pharmaceutical, Inc. New jersey 08869
Drug: Topiramate
25mg Tablets

Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence evaluation of Topiramate 25mg tablets

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. This study involved healthy adult male volunteers, 18-45 years of age, weighing at least 52 kg, who are within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
  2. Only medically healthy subjects with clinically normal laboratory profiles were enrolled in the study.

Exclusion Criteria:

  1. History or presence of significant:

    • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

    In addition, history or presence of:

    • Hypersensitivity or idiosyncratic reaction to topiramate
    • Nephrolithiasis or gout
    • Alcoholism or drug abuse within the past year
  2. Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
  3. Subjects who had any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
  4. Subjects who had used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
  5. Subjects who, through completion of the study, would have donated in excess of:

    • 500 mL of blood in 14 days, or
    • 500-750 mL of blood in 14 days (unless approved by the Principal Investigator),
    • 1000 mL of blood in 90 days,
    • 1250 mL of blood in 120 days,
    • 1500 mL of blood in 180 days,
    • 2000 mL of blood in 270 days,
    • 2500 mL of blood in 1 year,
  6. Subjects who had participated in another clinical trial within 28 days of study start.
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): NCT00901784

MDS Pharina Services (Clinical Research Center)
St. Laurent, Québec, Canada, H4R 2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited
More Information

Additional Information:
Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00901784     History of Changes
Other Study ID Numbers: 011972
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: May 2009

Keywords provided by Ranbaxy Inc.:
Topiramate fasting study

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