NCT00905567CompletedPhase 1
Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Tablets Administered as 2 x 25 mg Tablets in Healthy Subjects Under Fed Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Teva Pharmaceuticals USA
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)
Study Overview
Brief Summary
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg tablets (test) versus Topamax® (reference) administered as 2 x 25 mg tablets under fed conditions.
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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).
Arms & Interventions
Test First
Experimental
Topiramate 2 x 25 mg Tablet
Intervention: Topiramate 2 x 25 mg tablet (Drug)
Reference First
Active Comparator
Topamax® Tablet 2 x 25 mg
Intervention: Topamax® Tablet 2 x 25 mg (Drug)
Outcomes
Primary Outcomes
AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)
Time Frame: Blood samples collected over 96 hour period
Bioequivalence based on AUC0-72
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time Frame: Blood samples collected over 96 hour period
Bioequivalence based on AUC0-t
Cmax - Maximum Observed Concentration
Time Frame: Blood samples collected over 96 hour period
Bioequivalence based on Cmax
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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