NCT00684762

Fasted Bioavailability Study of Cilostazol Tablets, 100 mg

A Comparative Bioavailability Study of Cilostazol Tablets, 100mg Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mutual Pharmaceutical Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (1 x 100 mg tablet), or a single oral dose of the reference formulation, Pletal® (1 x 100 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Conditions

• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	Cilostazol 100 mg Tablets	Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours
DRUG	Cilostazol (Pletal®) 100 mg Tablets	Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.

Timeline

• Start date: 2004-03-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2008-05-28
• Last updated: 2009-12-22
• Results posted: 2009-12-22