A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
研究概览
简要总结
A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
详细描述
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19~55 years healthy male
- •Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
- •Subjects who agree to keep contraceptive methods during the clinical trial.
排除标准
- •Subjects who are allergic to investigational drug.
- •Subjects who have a medical history which can affect the clinical trial.
- •Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
- •Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
研究组 & 干预措施
Group 1 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2
干预措施: Rosuvastatin (Drug)
Group 1 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2
干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Group 2 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
干预措施: Telmisartan/Amlodipine (Drug)
Group 2 of part 1
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2
干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Group 1 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2
干预措施: Rosuvastatin (Drug)
Group 1 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2
干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)
Group 2 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2
干预措施: Telmisartan/Amlodipine (Drug)
Group 2 of part 2
Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2
干预措施: Rosuvastatin and Telmisartan/Amlodipine (Drug)
结局指标
主要结局
AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine
时间窗: 72hours, 144hours
次要结局
- AUClast,ss of Rosuvastatin(72hours)
- AUCinf,ss of Rosuvastatin(72hours)
- Tmax,ss of Rosuvastatin(72hours)
- t1/2 of Rosuvastatin(72hours)
- AUClast,ss of Telmisartan, Amlodipine(144hours)
- AUCinf,ss of Telmisartan, Amlodipine(144hours)
- Tmax,ss of Telmisartan, Amlodipine(144hours)
- t1/2 of Telmisartan, Amlodipine(144hours)