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Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

NCT00650052 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-04-23

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Zonisamide Capsules 100 mg

100mg, single dose fasting

DRUG

Zonegran® Capsules 100 mg

100mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Dorian Williams, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2003-12-31
Completion
2003-12-31

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 NCT00650052 on ClinicalTrials.gov