Topiramate 25 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Topiramate Tablets; Topamax® Tablets
Intervention MeSH terms: Topiramate
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

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 fasting
      conditions.
    

Eligibility criteria:

        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).