Cilostazol-Simvastatin Drug Interaction Study
- Conditions
- DyslipidemiasPeripheral Artery Disease
- Interventions
- Registration Number
- NCT02431013
- Lead Sponsor
- Ajou University School of Medicine
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 20
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
- Subject with known for hypersensitivity reaction to Cilostazol, Simvastatin or Pravastatin
- Previous whole blood donation within 60 days or component blood donation within 30 days
- Previous participation of other trial within 90 days
- Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simvastatin+Cilostazol Simvastatin Simvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8. Simvastatin+Cilostazol Cilostazol Simvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8. Pravastatin+Cilostazol Cilostazol Pravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8. Pravastatin+Cilostazol Pravastatin Pravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8.
- Primary Outcome Measures
Name Time Method AUC (area under the time-concentration curve) of Simvastatin up to 12 hours after Simvastatin dosing
- Secondary Outcome Measures
Name Time Method Cmax (maximum plasma concentration) of Pravastatin up to 12 hours after Pravastatin dosing AUC (area under the time-concentration curve) of Pravastatin up to 12 hours after Pravastatin dosing Cmax (maximum plasma concentration) of Simvastatin up to 12 hours after Simvastatin dosing
Trial Locations
- Locations (1)
Ajou University Medical Center
🇰🇷Suwon, Gyeonggi, Korea, Republic of