NCT02431013

Cilostazol-Simvastatin Drug Interaction Study

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Dyslipidemias
• Peripheral Artery Disease

Interventions

Type	Name	Description
DRUG	Simvastatin	Simvastatin 40 mg on Day 1 \& Day 8.
DRUG	Pravastatin	Pravastatin 20 mg on Day 1 \& Day 8.
DRUG	Cilostazol	Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-08-01
• First posted: 2015-04-30
• Last updated: 2015-05-01

Locations

1 site across 1 country: South Korea