An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin
研究概览
简要总结
Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination
详细描述
An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 19 aged and 45 aged in healthy male adult
- •Body weight more than 50kg and within ideal body weight ±20%
排除标准
- •Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
- •Have a gastrointestinal disease history that can effect drug absorption or surgery
- •SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<60mmHg
研究组 & 干预措施
Group 1
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
干预措施: CKD-333 formulation I (Drug)
Group 1
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
干预措施: CKD-333 formulation II (Drug)
Group 1
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
干预措施: CKD-330+D086 (Drug)
Group 2
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
干预措施: CKD-333 formulation I (Drug)
Group 2
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
干预措施: CKD-333 formulation II (Drug)
Group 2
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
干预措施: CKD-330+D086 (Drug)
Group 3
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
干预措施: CKD-333 formulation I (Drug)
Group 3
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
干预措施: CKD-333 formulation II (Drug)
Group 3
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
干预措施: CKD-330+D086 (Drug)
Group 4
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
干预措施: CKD-333 formulation I (Drug)
Group 4
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
干预措施: CKD-333 formulation II (Drug)
Group 4
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
干预措施: CKD-330+D086 (Drug)
Group 5
Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
干预措施: CKD-333 formulation I (Drug)
Group 5
Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
干预措施: CKD-333 formulation II (Drug)
Group 5
Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
干预措施: CKD-330+D086 (Drug)
Group 6
Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)
干预措施: CKD-333 formulation I (Drug)
Group 6
Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)
干预措施: CKD-333 formulation II (Drug)
Group 6
Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)
干预措施: CKD-330+D086 (Drug)
结局指标
主要结局
Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin
时间窗: 0~72hours
AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin
时间窗: 0~72hours
次要结局
- Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin(0~72hours)
- AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin(0~72hours)
- t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin(0~72hours)
- CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin(0~72hours)
- Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin(0~72hours)