Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Topiramate

• Registration Number: NCT00902473
• Lead Sponsor: Ranbaxy Laboratories Limited

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 fed conditions.

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.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2001-09
• Study Completion: 2001-10
• Status Verified: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Last Update Submitted: 2009-05-14
• Study First Posted: 2009-05-15
• Last Update Posted: 2009-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Topiramate	25 mg Topiramate tablets of Ranbaxy Laboratories, Ltd
2	Topiramate	(Topamax®) 25 mg Topiramate tablets of Ortho-McNeil Pharmaceutical, Inc. New jersey 08869

Primary Outcome Measures

Name	Time	Method
Bioequivalence evaluation of topiramate 25mg tablets

Trial Locations

Locations (1)

MDS Pharina Services (Clinical Research Center); 🇨🇦 Quebec, Canada