NCT01415466已完成1 期
A Randomized, Open Label, Multiple-Dose, Cross-over Clinical Study to Investigate Pharmacokinetics and Drug-Drug Interaction Between Rosuvastatin and CS-866 in Healthy Male Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCtau
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male volunteers aged 20 to 50 years
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
排除标准
- •A subject who had any allergic history to any drug.
- •A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
- •History or suspicion of current drug abuse
- •A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
- •Within 1 month: drug known CYP inducer or inhibitor
- •Within 2 weeks: Prescribed or herbal medicine
- •Within 1 weeks: OTC medicine
- •Within 2 days: Consumption of caffeine
- •A subject who had participated in any other clinical study within the last 2 weeks
- •A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
研究组 & 干预措施
R
Experimental
multiple dose of Rosuvastatin 20mg
干预措施: Cresto (Drug)
O
Experimental
multiple dose of CS-866 40mg
干预措施: Olmetec (Drug)
R+O
Experimental
multiple dose of the combination of Rosuvastatin 20mg and CS-866 40mg
干预措施: Cresto, Olmetec (Drug)
结局指标
主要结局
AUCtau
时间窗: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.((in case of CS-866, for 48 hours)
Css,max
时间窗: Multiple blood samples will be collected for 72 hours after last dosing in each of the periods.(in case of CS-866, for 48 hours)
次要结局
- AUCss,last(Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours))
- AUCss,inf(Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours))
- Css,min(Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours))
- T1/2(Multiple blood samples will be collected for 72 hours after last dosing in each of the periods. (in case of CS-866, for 48 hours))
研究者
研究点 (1)
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