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Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets

NCT00685165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2010-01-20

Study results available
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Summary

The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions.

Conditions

  • Therapeutic Equivalency

Interventions

DRUG

Primidone 50 mg Tablet

50 mg tablet administered after an overnight fast of at least 10 hours.

DRUG

Primidone (Mysoline®) 50 mg Tablet

50 mg tablet administered after an overnight fast of at least 10 hours.

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-06-30
Completion
2004-06-30

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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 NCT00685165 on ClinicalTrials.gov