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Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902473
First Posted: May 15, 2009
Last Update Posted: May 15, 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:
Ranbaxy Inc.
  Purpose
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 fed conditions.

Condition Intervention
Healthy Drug: Topiramate

Study Type: Interventional
Study Design: 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 Fed Conditions

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence evaluation of topiramate 25mg tablets

Enrollment: 18
Study Start Date: September 2001
Study Completion Date: October 2001
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 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.
  Eligibility

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
Criteria

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 used 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 have 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): NCT00902473


Locations
Canada
MDS Pharina Services (Clinical Research Center)
Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00902473     History of Changes
Other Study ID Numbers: 011973
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: May 15, 2009
Last Verified: May 2009

Keywords provided by Ranbaxy Inc.:
Topiramate fed study

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