Topiramate 25 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00905164
First received: May 18, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg capsules (test) versus Topamax® (reference) administered as 2 x 25 mg capsules under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Topiramate Capsules, 25 mg
Drug: Topamax® Capsules, 25 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Topiramate 25 mg Capsules and Topamax® 25 mg Sprinkle Capsules Administered as 2 x 25 mg Capsules in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2002
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test First
Topiramate Capsules, 25 mg
Drug: Topiramate Capsules, 25 mg
Topiramate Capsules, 2 x 25 mg
Active Comparator: Reference First
Topamax® Capsules, 25 mg
Drug: Topamax® Capsules, 25 mg
Topamax® Capsules, 2 x 25 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905164

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Eric Bicrell, MD Anapharm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00905164     History of Changes
Other Study ID Numbers: 02134
Study First Received: May 18, 2009
Results First Received: June 1, 2009
Last Updated: August 14, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 24, 2014