DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 主要终点
- AUClast
研究概览
简要总结
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212
详细描述
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers
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
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 17.5~30.5
- •signed the informed consent form prior to the study participation
排除标准
- •Clinically significant disease
- •Previously donate whole blood within 60 days or component blood within 30 days
- •Clinically significant allergic disease
- •Taken IP in other trial within 90 days
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
A group
Amlodipine and Rosuvastatin, DP-R212
干预措施: DP-R212 (Drug)
A group
Amlodipine and Rosuvastatin, DP-R212
干预措施: Amlodipine (Drug)
A group
Amlodipine and Rosuvastatin, DP-R212
干预措施: Rosuvastatin (Drug)
B group
DP-R212, Amlodipine and Rosuvastatin
干预措施: DP-R212 (Drug)
B group
DP-R212, Amlodipine and Rosuvastatin
干预措施: Amlodipine (Drug)
B group
DP-R212, Amlodipine and Rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
AUClast
时间窗: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
Cmax
时间窗: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr
次要结局
未报告次要终点