- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905346
Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions
August 14, 2009 updated by: Teva Pharmaceuticals USA
Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Capsules and Topamax® 25 mg Capsules Administered as the Content of 2 x 25 mg Capsules Mixed With Applesauce in Healthy Subjects Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption or topiramate 25 mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg capsules mixed with applesauce under fasting conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
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
-
-
Quebec
-
Sainte-Foy, Quebec, Canada, G1V 2K8
- Anapharm Inc.
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects will be females and/or males, non-smokers, 18 years of age or older
- Subjects should read, sign and date an Informed Consent Form prior to any study procedures.
- Female subjects will be post-menopausal or surgically sterilized.
- Post menopausal status is defined as absence of menses for the past 12 months or bilateral oophorectomy at least 6 months ago or hysterectomy with bilateral oophorectomy at least 6 months ago.
- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation aat least 6 months ago.
Exclusion Criteria:
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any history or presence of significant neurological, hepatic, renal, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Any clinically significant abnormality found during medical screening.
- Abnormal laboratory tests judged clinically significant.
- Positive urine drug screen at screening.
- Positive alcohol breath test at screening.
- Subjects who use tobacco in any form will not be eligible to participate in this study. Three months abstinence is required.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
- ECG or vital sign abnormalities (clinically significant).
- Subjects with BMI greater than or equal to 30.0.
- History of significant alcohol abuse within 6 months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subjects participation in this study.
- History of allergic reactions to topiramate.
- Use of any drugs known to induce or inhibit hepatic drug metabolism, use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
Additional exclusion criteria for females only:
• Positive urine pregnancy test at screening (performed on all females).
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Test First
Topiramate Capsules 25 mg
|
Topiramate Capsules 2 x 25 mg
Applesauce
|
ACTIVE_COMPARATOR: Reference First
Topamax® 25 mg Capsule
|
Applesauce
Topamax® Capsule 2 x 25 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 168 hour period
|
Bioequivalence based on Cmax
|
Blood samples collected over 168 hour period
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time Frame: Blood samples collected over 168 hour period
|
Bioequivalence based on AUC0-inf
|
Blood samples collected over 168 hour period
|
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
Time Frame: Blood samples collected over 168 hour period
|
Bioequivalence based on AUC0-t
|
Blood samples collected over 168 hour period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2002
Primary Completion (ACTUAL)
July 1, 2002
Study Completion (ACTUAL)
July 1, 2002
Study Registration Dates
First Submitted
May 18, 2009
First Submitted That Met QC Criteria
May 19, 2009
First Posted (ESTIMATE)
May 20, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 23, 2009
Last Update Submitted That Met QC Criteria
August 14, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02136
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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