- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901784
Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions
June 17, 2009 updated by: Ranbaxy Laboratories Limited
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 Fasting Conditions
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 fasting conditions.
Study Overview
Detailed Description
This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 4 alternates.
All 28 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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
St. Laurent, Québec, Canada, H4R 2N6
- MDS Pharina Services (Clinical Research Center)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 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 had participated in another clinical trial within 28 days of study start.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
25 mg Topiramate tablets of Ranbaxy Laboratories, Ltd
|
25mg Tablets
|
Active Comparator: 2
(Topamax®) 25 mg Topiramate tablets of Ortho-McNeil Pharmaceutical, Inc.
New jersey 08869
|
25mg Tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Bioequivalence evaluation of Topiramate 25mg tablets
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
September 1, 2001
Study Completion (Actual)
October 1, 2001
Study Registration Dates
First Submitted
May 13, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 14, 2009
Study Record Updates
Last Update Posted (Estimate)
June 18, 2009
Last Update Submitted That Met QC Criteria
June 17, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011972
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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