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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Simvastatin 40 mg on Day 1 \& Day 8.
Pravastatin 20 mg on Day 1 \& Day 8.
Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
RECRUITINGAUC (area under the time-concentration curve) of Simvastatin
Time frame: up to 12 hours after Simvastatin dosing
Cmax (maximum plasma concentration) of Simvastatin
Time frame: up to 12 hours after Simvastatin dosing
Cmax (maximum plasma concentration) of Pravastatin
Time frame: up to 12 hours after Pravastatin dosing
AUC (area under the time-concentration curve) of Pravastatin
Time frame: up to 12 hours after Pravastatin dosing
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