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Fasting Bioavailability Study of Zonisamide Capsules

NCT00685139 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2010-01-26

Study results available
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Summary

The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Zonisamide 100 mg Capsule

100 mg capsule administered after an overnight fast.

DRUG

Zonisamide (Zonegran®) 100 mg Capsule

100 mg capsule administered after an overnight fast.

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-03-31
Completion
2005-03-31

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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 NCT00685139 on ClinicalTrials.gov