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

NCT ID: NCT00939705

Last Updated: 2011-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL

Brief 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 adult subjects under fed conditions.
• Clinical Design:

• Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Torrent Topiramate

Group Type: EXPERIMENTAL

topiramate

Intervention Type: DRUG

Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

Topamax

Group Type: ACTIVE_COMPARATOR

topiramate

Intervention Type: DRUG

Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

Interventions

topiramate

Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

Intervention Type: DRUG

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:

1. 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.

2. 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.

• In addition, any one (1) of the conditions listed below will exclude a subject from the study:

1. History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months.

2. History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.

3. History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.

4. History of treatment for asthma within the past five (5) years.

5. History of predisposition to renal calculi.

6. History of surgery within the past eight (8) weeks.

7. History of application of tattoo(s) within the past 30 days.

8. History of body piercing(s) within the past 30 days.

9. Females who are pregnant or lactating.

10. 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:

1. Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Torrent Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Locations

Gateway Medical Research, Inc.

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

06TOR02

Identifier Type: -

Identifier Source: org_study_id