A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Css,max
研究概览
简要总结
The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a day for 6 days.
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
- •Healthy male subjects between the ages of 19 and 55 years
- •Subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years
- •Healthy Subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
- •Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •Any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy)
- •Twofold or more than upper limit of normal range in laboratory test for ALT or AST
- •Participating in other clinical trial study within 2 month preceding the first dose of investigational product
- •History of significant alcohol abuse or drug abuse within one year prior to the screening
- •Whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- •Unwilling or unable to comply with the lifestyle guidelines described in this protocol
- •Subjects who are inadequate for this study to participate judged by investigator
研究组 & 干预措施
Part1-A
The Part1-A of groups take Telmisartan once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.
干预措施: Telmisartan (Drug)
Part1-A
The Part1-A of groups take Telmisartan once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.
干预措施: Atorvastatin (Drug)
Part1-B
The Part1-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan once a day for 6 days in period 2.
干预措施: Telmisartan (Drug)
Part1-B
The Part1-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan once a day for 6 days in period 2.
干预措施: Atorvastatin (Drug)
Part2-A
The Part2-A of groups take Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.
干预措施: Telmisartan (Drug)
Part2-A
The Part2-A of groups take Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.
干预措施: Atorvastatin (Drug)
Part2-B
The Part2-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Atorvastatin once a day for 6 days in period 2.
干预措施: Telmisartan (Drug)
Part2-B
The Part2-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Atorvastatin once a day for 6 days in period 2.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Css,max
时间窗: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
AUCt(0-24)
时间窗: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)
次要结局
- Css,av(First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times))
- t1/2(First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times))
- CL/F(First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times))
- Vd/F(First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times))
- Css,min(First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times))
- Tss,max(First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times))