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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939692
First Posted: July 15, 2009
Last Update Posted: July 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited
  Purpose
  • 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.

Condition Intervention Phase
Healthy Drug: Topiramate Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Topiramate (2 x 25 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Topamax®, Ortho-McNeil Neurologics, Inc.)in Fasted, Healthy, Adult Subjects

Resource links provided by NLM:


Further study details as provided by Torrent Pharmaceuticals Limited:

Primary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]
    The maximum or peak concentration that the drug reaches in the plasma

  • Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]
    The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)

  • The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞) [ Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. ]
    The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.


Enrollment: 26
Study Start Date: January 2007
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Torrent Topiramate
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals)
Drug: Topiramate
Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Active Comparator: Topamax
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
Drug: Topiramate
Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939692


Locations
United States, Missouri
Gateway Medical Research, Inc.
St, Charles, Missouri, United States, 63301
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

Responsible Party: Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00939692     History of Changes
Other Study ID Numbers: 06TOR01
First Submitted: July 13, 2009
First Posted: July 15, 2009
Results First Submitted: July 22, 2009
Results First Posted: July 16, 2013
Last Update Posted: July 16, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents