Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

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.

Inclusion criteria

• 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).
• Only medically healthy subjects with clinically normal laboratory profiles were enrolled in the study.

Exclusion criteria

• 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.
• Subjects who had been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
• 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.
• 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.
• 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.
• Subjects who have participated in another clinical trial within 28 days of study start.