A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Telmisartan, Amlodipine, Rosuvastatin Cmax
研究概览
简要总结
This is a phase 1, open label, two-cohort, single-sequence, crossover study
详细描述
This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
排除标准
- •History of and clinically significant disease
- •A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- •Administration of other investigational products within 3 months prior to the first dosing
- •Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
- •Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)
研究组 & 干预措施
Twynsta 80/5mg
Day 1 ~ Day 9 : Twynsta 80/5mg / Day 10 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
干预措施: Twynsta 80/5mg (Drug)
Twynsta 80/5mg
Day 1 ~ Day 9 : Twynsta 80/5mg / Day 10 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
干预措施: Crestor 20mg (Drug)
Crestor 20mg
Day 1 ~ Day 5 : Crestor 20mg / Day 6 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
干预措施: Twynsta 80/5mg (Drug)
Crestor 20mg
Day 1 ~ Day 5 : Crestor 20mg / Day 6 ~ Day 14 : Twynsta 80/5mg + Crestor 20mg
干预措施: Crestor 20mg (Drug)
结局指标
主要结局
Telmisartan, Amlodipine, Rosuvastatin Cmax
时间窗: 0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin AUCτ
时间窗: 0 - 24 hr
次要结局
- Telmisartan, Amlodipine, Rosuvastatin Tmax(0 - 24 hr)
- Telmisartan, Amlodipine, Rosuvastatin Cmin(0 - 24 hr)