Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00902473
First received: May 13, 2009
Last updated: May 14, 2009
Last verified: May 2009
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902473

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

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00902473     History of Changes
Other Study ID Numbers: 011973
Study First Received: May 13, 2009
Last Updated: May 14, 2009
Health Authority: Canada: Health Canada

Keywords provided by Ranbaxy Inc.:
Topiramate fed study

Additional relevant MeSH terms:
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on April 16, 2014