Topiramate 25 mg Tablets Under Fasting Conditions

NCT00905606 | Completed Phase 1 Results

• 1 other identifier: 01179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 96 hour period

• AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant)

  Bioequivalence based on AUC0-72

  Blood samples collected over 96 hour period

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

  Bioequivalence based on AUC0-t

  Blood samples collected over 96 hour period

Study Arms (2)

1

EXPERIMENTAL

Topiramate Tablets, 25 mg

Drug: Topiramate Tablets

2

ACTIVE COMPARATOR

Topamax® Tablets, 25 mg

Drug: Topamax® Tablets

Interventions

Topiramate Tablets DRUG

1

Topamax® Tablets DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Topiramate

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Benoit Girard, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: June 1, 2001
• Primary Completion: June 1, 2001
• Study Completion: June 1, 2001
• Last Updated: August 19, 2024
• Results First Posted: September 23, 2009

Record last verified: 2024-08

Locations

CA (1)