Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions

NCT00905346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-20

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Topiramate 25 mg Capsules

Topiramate Capsules 2 x 25 mg

DRUG

Topamax® 25 mg Capsules

Topamax® Capsule 2 x 25 mg

OTHER

Applesauce

Applesauce

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Benoit Girard, MD · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00905346 on ClinicalTrials.gov