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 D090 in Healthy Male Adults
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUClast of Candesartan
研究概览
简要总结
The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.
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 D090 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
- •Healthy male adults aged 19 to 45 years
- •Body weight more than 50kg and within ideal body weight ±20%
- •signed informed consent form
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
- •Systolic Blood pressure≥140mmHg or Systolic Blood pressure<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure<60mmHg
研究组 & 干预措施
Group 3
- Period 1: CKD-333, formula II
- Period 2: CKD-330, D090
- Period 3: CKD-333, formula I
干预措施: CKD-333, formula II (Drug)
Group 3
- Period 1: CKD-333, formula II
- Period 2: CKD-330, D090
- Period 3: CKD-333, formula I
干预措施: CKD-330, D090 (Drug)
Group 4
- Period 1: CKD-333, formula II
- Period 2: CKD-333, formula I
- Period 3: CKD-330, D090
干预措施: CKD-333, formula I (Drug)
Group 4
- Period 1: CKD-333, formula II
- Period 2: CKD-333, formula I
- Period 3: CKD-330, D090
干预措施: CKD-333, formula II (Drug)
Group 1
- Period 1: CKD-333, formula I
- Period 2: CKD-333, formula II
- Period 3: CKD-330, D090
干预措施: CKD-333, formula I (Drug)
Group 1
- Period 1: CKD-333, formula I
- Period 2: CKD-333, formula II
- Period 3: CKD-330, D090
干预措施: CKD-333, formula II (Drug)
Group 1
- Period 1: CKD-333, formula I
- Period 2: CKD-333, formula II
- Period 3: CKD-330, D090
干预措施: CKD-330, D090 (Drug)
Group 2
- Period 1: CKD-333, formula I
- Period 2: CKD-330, D090
- Period 3: CKD-333, formula II
干预措施: CKD-333, formula I (Drug)
Group 2
- Period 1: CKD-333, formula I
- Period 2: CKD-330, D090
- Period 3: CKD-333, formula II
干预措施: CKD-333, formula II (Drug)
Group 2
- Period 1: CKD-333, formula I
- Period 2: CKD-330, D090
- Period 3: CKD-333, formula II
干预措施: CKD-330, D090 (Drug)
Group 3
- Period 1: CKD-333, formula II
- Period 2: CKD-330, D090
- Period 3: CKD-333, formula I
干预措施: CKD-333, formula I (Drug)
Group 4
- Period 1: CKD-333, formula II
- Period 2: CKD-333, formula I
- Period 3: CKD-330, D090
干预措施: CKD-330, D090 (Drug)
Group 5
- Period 1: CKD-330, D090
- Period 2: CKD-333, formula I
- Period 3: CKD-333, formula II
干预措施: CKD-333, formula I (Drug)
Group 5
- Period 1: CKD-330, D090
- Period 2: CKD-333, formula I
- Period 3: CKD-333, formula II
干预措施: CKD-333, formula II (Drug)
Group 5
- Period 1: CKD-330, D090
- Period 2: CKD-333, formula I
- Period 3: CKD-333, formula II
干预措施: CKD-330, D090 (Drug)
Group 6
- Period 1: CKD-330, D090
- Period 2: CKD-333, formula II
- Period 3: CKD-333, formula I
干预措施: CKD-333, formula I (Drug)
Group 6
- Period 1: CKD-330, D090
- Period 2: CKD-333, formula II
- Period 3: CKD-333, formula I
干预措施: CKD-333, formula II (Drug)
Group 6
- Period 1: CKD-330, D090
- Period 2: CKD-333, formula II
- Period 3: CKD-333, formula I
干预措施: CKD-330, D090 (Drug)
结局指标
主要结局
AUClast of Candesartan
时间窗: 0 hour ~ 72 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Candesartan
AUClast of Amlodipine
时间窗: 0 hour ~ 72 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Amlodipine
AUClast of Atorvastatin
时间窗: 0 hour ~ 72 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Atorvastatin
Cmax of Amlodipine
时间窗: 0 hour ~ 72 hour after drug administration
Maximum plasma concentration of Amlodipine
Cmax of Candesartan
时间窗: 0 hour ~ 72 hour after drug administration
Maximum plasma concentration of Candesartan
Cmax of Atorvastatin
时间窗: 0 hour ~ 72 hour after drug administration
Maximum plasma concentration of Atorvastatin
次要结局
- AUCinf of Candesartan(0 hour ~ 72 hour after drug administration)
- AUCinf of Amlodipine(0 hour ~ 72 hour after drug administration)
- AUCinf of 2-hydroxy atorvastatin(0 hour ~ 72 hour after drug administration)
- Tmax of Candesartan(0 hour ~ 72 hour after drug administration)
- Tmax of Amlodipine(0 hour ~ 72 hour after drug administration)
- Tmax of Atorvastatin(0 hour ~ 72 hour after drug administration)
- Tmax of 2-hydroxy atorvastatin(0 hour ~ 72 hour after drug administration)
- T1/2 of Candesartan(0 hour ~ 72 hour after drug administration)
- T1/2 of Amlodipine(0 hour ~ 72 hour after drug administration)
- T1/2 of Atorvastatin(0 hour ~ 72 hour after drug administration)
- T1/2 of 2-hydroxy atorvastatin(0 hour ~ 72 hour after drug administration)
- clearance of Candesartan(0 hour ~ 72 hour after drug administration)
- clearance of Atorvastatin(0 hour ~ 72 hour after drug administration)
- clearance of 2-hydroxy atorvastatin(0 hour ~ 72 hour after drug administration)
- AUCinf of Atorvastatin(0 hour ~ 72 hour after drug administration)
- clearance of Amlodipine(0 hour ~ 72 hour after drug administration)
- Vd/F of Candesartan(0 hour ~ 72 hour after drug administration)
- Vd/F of Amlodipine(0 hour ~ 72 hour after drug administration)
- Vd/F of Atorvastatin(0 hour ~ 72 hour after drug administration)
- Vd/F of 2-hydroxy atorvastatin(0 hour ~ 72 hour after drug administration)