A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R208 (Candesartan Cilexetil and Rosuvastatin Calcium Fixed Dose Combinations) in Comparison to Each Component Administered Alone in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male 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 55 Years（Adult）
- 性别
- Male
- 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 14 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
Group A
combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order
干预措施: DP-R208 (Drug)
Group A
combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order
干预措施: Candesartan cilexetil (Drug)
Group A
combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order
干预措施: Rosuvastatin (Drug)
Group B
DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order
干预措施: DP-R208 (Drug)
Group B
DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order
干预措施: Candesartan cilexetil (Drug)
Group B
DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: up to 72 hours post dose
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 72 hours post dose
次要结局
未报告次要终点