Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
-  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.
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.