Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions
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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2001
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedMay 15, 2009
May 1, 2009
Same day
May 13, 2009
May 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence evaluation of topiramate 25mg tablets
Study Arms (2)
1
EXPERIMENTAL25 mg Topiramate tablets of Ranbaxy Laboratories, Ltd
2
ACTIVE COMPARATOR(Topamax®) 25 mg Topiramate tablets of Ortho-McNeil Pharmaceutical, Inc. New jersey 08869
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- mL of blood in 14 days, or
- mL of blood in 14 days (unless approved by the Principal Investigator),
- ml. of blood in 90 days,
- mL of blood in 120 days,
- mL of blood in 180 days,
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MDS Pharina Services (Clinical Research Center)
Québec, H4R 2N6, Canada
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
September 1, 2001
Primary Completion
September 1, 2001
Study Completion
October 1, 2001
Last Updated
May 15, 2009
Record last verified: 2009-05