NCT01493856已完成1 期
A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年1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
- 58
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetic characteristics of combination of rosuvastatin and CS-866 and DWJ1276 alone.
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
Rosuvastatin+Olmesartan
Active Comparator
single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
干预措施: Cresto (Drug)
Rosuvastatin+Olmesartan
Active Comparator
single dose of Rosuvastatin 20mg and olmesartan medoxomil(CS-866) 40mg
干预措施: Olmetec (Drug)
DWJ1276
Experimental
Single dose of DWJ1276
干预措施: DWJ1276 (Drug)
结局指标
主要结局
AUClast
时间窗: 18 time points up to 72 hours
Cmax
时间窗: 18 time points up to 72 hours
次要结局
- AUCinf(18 time points up to 72 hours)
- T1/2(18 time points up to 72 hours)
- %AUCextra(18 time points up to 72 hours)
- Tmax(18 time points up to 72 hours)
研究者
研究点 (1)
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