Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Condition: Healthy
Intervention: Topiramate
Intervention description: Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Intervention MeSH terms: Topiramate
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  Objective:

             -  Compare the bioequivalence of a test topiramate formulation (Torrent
                Pharmaceuticals Limited) to an equivalent oral dose of the commercially available
                topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26
                adult subjects under fasted conditions.

        -  Clinical Design:

             -  Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human
                adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male or Female; similar proportions of each preferred.

          -  Age: At least 18 - 55 years (inclusive).

          -  Weight: BMI (Body Mass Index) 19 kg/m2 - 30 kg/m2 (inclusive).

          -  Qualifying subjects must be in good health and physical condition as determined by
             medical history, complete physical examination, and laboratory tests, all obtained
             within four (4) weeks prior to study start. The subject may not have a history of
             significant past illness expected to affect the investigation. The normal status of
             subjects will be confirmed by the following procedures:

               -  Laboratory Tests: Serum pregnancy test (female subjects only), hemoglobin,
                  hematocrit, RBC, WBC, platelet count, differential count, serum electrolytes (Na,
                  K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline
                  phosphatase, urinalysis, drugs of abuse, HIV, Hepatitis B, and Hepatitis C will
                  be done for screening purposes.

               -  Laboratory values which are greater than 20% of the normal range will not qualify
                  unless specifically accepted by a physician who is an investigator or
                  sub-investigator for the clinical trial. Results of a serum pregnancy test
                  (female subjects only), HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be
                  negative or non-reactive for the subject to qualify for the study.

               -  Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all
                  subjects. The original tracings, plus interpretation, will be included in the
                  case report form packet.

          -  Subjects must read and sign the Consent Form.

        Exclusion Criteria:

          -  Subjects not complying with the above inclusion criteria must be excluded from the
             study.

          -  In addition, any one (1) of the conditions listed below will exclude a subject from
             the study:

               -  History of treatment for alcoholism, substance abuse, or drug abuse within the
                  past 24 months.

               -  History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or
                  other serious illness.

               -  History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon
                  cancer, or chronic colitis, including Crohn's disease.

               -  History of treatment for asthma within the past five (5) years.

               -  History of predisposition to renal calculi.

               -  History of surgery within the past eight (8) weeks.

               -  History of application of tattoo(s) within the past 30 days.

               -  History of body piercing(s) within the past 30 days.

               -  Females who are pregnant or lactating.

               -  History of hypersensitivity to topiramate or any anticonvulsant medication.

          -  Conditions upon screening which might contraindicate or require that caution be used
             in the administration of topiramate, including:

               -  Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm
                  Hg.

               -  Heart rate less than 50 beats per minute after a 5-minute rest in a seated
                  position.

          -  Inability to read and/or sign the consent form.

          -  Treatment with any other investigational drug during the 30 days prior to the initial
             dosing for this study.

          -  Subjects who have donated blood within 30 days prior to the initial dosing for this
             study.

          -  Subjects who smoke more than 10 cigarettes per day.

          -  Subjects who do not tolerate venipuncture.

          -  Subjects who have difficulty fasting or consuming standardized meals.