Cilostazol-Simvastatin Drug Interaction Study

Dyslipidemias Clinical Trial

Official title: A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers

Status Recruiting

Clinical Trial Summary

This is a randomized, open-label, single & multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin & pravastatin in healthy male volunteers

Clinical Trial Description

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).

On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.

From Day 2 ~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Peripheral Arterial Disease
• Peripheral Artery Disease

• NCT number: NCT02431013
• Study type: Interventional
• Source: Ajou University School of Medicine
• Contact: Doo-Yeoun Cho, MD
• Phone: +82-31-219-4271
• Email: dooycho@ajou.ac.kr
• Status: Recruiting
• Phase: Phase 1
• Start date: April 2015