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Fed Bioavailability Study of Zonisamide Capsules

NCT00687167 · 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 the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Zonisamide 100 mg Capsule

100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

DRUG

Zonisamide (Zonegran®) 100 mg Capsule

100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • James D Carlson, Pharm.D. · PRACS

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

Countries

  • United States

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 NCT00687167 on ClinicalTrials.gov