A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC (area under the time-concentration curve) of Simvastatin
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Simvastatin+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.
干预措施: Simvastatin (Drug)
Simvastatin+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.
干预措施: Cilostazol (Drug)
Pravastatin+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.
干预措施: Pravastatin (Drug)
Pravastatin+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.
干预措施: Cilostazol (Drug)
结局指标
主要结局
AUC (area under the time-concentration curve) of Simvastatin
时间窗: up to 12 hours after Simvastatin dosing
次要结局
- 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)
研究者
Doo-Yeoun Cho
Assistant Professor
Ajou University School of Medicine