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Topiramate 25 mg Capsules Under Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Topiramate Capsules, 25 mg (Drug); Topamax® Capsules, 25 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Eric Bicrell, MD, Principal Investigator, Affiliation: Anapharm

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec G1V 2K8, Canada
Additional Information

Starting date: June 2002
Last updated: August 14, 2009

Page last updated: August 23, 2015

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