NCT03657472已完成1 期
An Open-label, Randomized, Single-dose, 3-period Replicated Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-30061 Alone and Co-administration of Amlodipine/Valsartan and Atorvastatin in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- AUCt of valsartan
研究概览
简要总结
To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 aged 19 to 55 years at the time of signing informed consent form.
- •Subject with BMI from 19kg/m^2 to 27kg/m^2
- •Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study
排除标准
- •Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
- •Subject who fall under the criteria below in laboratory test.
- •AST/ALT, total bilirubin, GGT, Uric acid > UNL (upper normal limit) x 1.5
- •CPK > UNL x 2.5
- •CrCL < 60mL/min
- •Subject who fall under the criteria below in Blood Pressure test (siSBP < 100mmHg/siSBP ≥ 150mmHg or siDBP < 70mmHg/siDBP ≥ 100mmHg)
研究组 & 干预措施
Sequence 1(RTR)
Experimental
干预措施: Exforge® 5/160mg & Lipitor® 20mg (Drug)
Sequence 1(RTR)
Experimental
干预措施: CJ-30061 (Drug)
Sequence 2(RRT)
Experimental
干预措施: CJ-30061 (Drug)
Sequence 2(RRT)
Experimental
干预措施: Exforge® 5/160mg & Lipitor® 20mg (Drug)
Sequence 3(TRR)
Experimental
干预措施: CJ-30061 (Drug)
Sequence 3(TRR)
Experimental
干预措施: Exforge® 5/160mg & Lipitor® 20mg (Drug)
结局指标
主要结局
AUCt of valsartan
时间窗: Up to 72 hours
Cmax of valsartan
时间窗: Up to 72 hours
Cmax of amlodipine
时间窗: Up to 72 hours
Cmax of atorvastatin
时间窗: Up to 72 hours
AUCt of atorvastatin
时间窗: Up to 72 hours
AUCt of amlodipine
时间窗: Up to 72 hours
次要结局
- AUCinf of atorvastatin(Up to 72 hours)
- t1/2 of amlodipine(Up to 72 hours)
- tmax of valsartan(Up to 72 hours)
- t1/2 of atorvastatin(Up to 72 hours)
- AUCinf of amlodipine(Up to 72 hours)
- t1/2 of 2-OH atorvastatin(Up to 72 hours)
- AUCinf of 2-OH atorvastatin(Up to 72 hours)
- tmax of amlodipine(Up to 72 hours)
- tmax of atorvastatin(Up to 72 hours)
- t1/2 of valsartan(Up to 72 hours)
- AUCinf of valsartan(Up to 72 hours)
- AUCt of 2-OH atorvastatin(Up to 72 hours)
- tmax of 2-OH atorvastatin(Up to 72 hours)
- Cmax of 2-OH atorvastatin(Up to 72 hours)
研究者
研究点 (1)
Loading locations...
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