NCT02089399已完成1 期
An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年5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
- 32
- 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 amlodipine, olmesartan and rosuvastatin in healthy adult 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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 19 - 55 years
- •A body mass index in the range 19 - 27 kg/m2
- •Willingness to participate during the entire study period
- •Written informed consent after being fully informed about the study procedures
排除标准
- •Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
- •History of clinically significant drug hypersensitivity
- •Use of medication within 7 days before the first dose
- •Heavy drinker (>140 g/week)
- •Whole blood donation during 60 days before the study
- •Judged not eligible for study participation by investigator
研究组 & 干预措施
Treatment AB
Experimental
S->S+C
干预措施: Sevikar(amlodipne/olmesartan) (Drug)
Treatment AB
Experimental
S->S+C
干预措施: crestor(Rosuvastatin) (Drug)
Treatment C
Experimental
C
干预措施: crestor(Rosuvastatin) (Drug)
结局指标
主要结局
AUCtau
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
Css,max
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment
次要结局
- Tss,max(Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment)
- Css,min(Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment)
研究者
研究点 (1)
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