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Fasted Bioavailability Study of Cilostazol Tablets, 50mg

NCT00685802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2009-12-22

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 cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.

Conditions

  • Therapeutic Equivalency, Healthy

Interventions

DRUG

Cilostazol 50 mg Tablets

Cilostazol (2 x 50 mg tablets) administered after an overnight fast of at least 10 hours

DRUG

Cilostazol (Pletal®) 50 mg Tablets

Cilostazol (Pletal® Tablets, 2 x 50mg) administered after an overnight fast of at least 10 hours.

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Dilip K Guha-Ray, M.D. · BASi Baltimore Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2004-07-31
Completion
2004-07-31

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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 NCT00685802 on ClinicalTrials.gov