Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- AUC of Reference 2
研究概览
简要总结
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male who are ≥19, <50 years old
- •Man who weights over 55kg and whose BMI is 18~30(kg/m2)
- •Man who doesn't have any chronic disease or history of disease
排除标准
- •man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry
研究组 & 干预措施
Reference2
single(Reference2) -> combination(Reference1+Reference2)
干预措施: Rosuvastatin (Drug)
Reference1
single(Reference1) -> combination(Reference1+Reference2)
干预措施: Telmisartan (Drug)
Reference1
single(Reference1) -> combination(Reference1+Reference2)
干预措施: Amlodipine (Drug)
Reference1
single(Reference1) -> combination(Reference1+Reference2)
干预措施: Rosuvastatin (Drug)
Reference2
single(Reference2) -> combination(Reference1+Reference2)
干预措施: Telmisartan (Drug)
Reference2
single(Reference2) -> combination(Reference1+Reference2)
干预措施: Amlodipine (Drug)
结局指标
主要结局
AUC of Reference 2
时间窗: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
AUC of Reference 1
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 1
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 2
时间窗: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
次要结局
未报告次要终点