Status:
COMPLETED
Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
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 cond...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2001
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00902473
Start Date
September 1 2001
End Date
October 1 2001
Last Update
May 15 2009
Active Locations (1)
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1
MDS Pharina Services (Clinical Research Center)
Québec, Canada, H4R 2N6