Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

• Status: Completed
• Trial end date: 2001-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Topiramate

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.