DP-R208 Pharmacokinetic Study Phase I
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
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-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 18~30
- •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
TR group
DP-R208 and combination dose of Candesartan and Rosuvastatin in order
干预措施: Rosuvastatin (Drug)
RT group
combination dose of Candesartan and Rosuvastatin and DP-R208 in order
干预措施: DP-R208 (Drug)
RT group
combination dose of Candesartan and Rosuvastatin and DP-R208 in order
干预措施: Candesartan cilexetil (Drug)
RT group
combination dose of Candesartan and Rosuvastatin and DP-R208 in order
干预措施: Rosuvastatin (Drug)
TR group
DP-R208 and combination dose of Candesartan and Rosuvastatin in order
干预措施: DP-R208 (Drug)
TR group
DP-R208 and combination dose of Candesartan and Rosuvastatin in order
干预措施: Candesartan cilexetil (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 48 hours post dose
Peak Plasma Concentration (Cmax)
时间窗: up to 48 hours post dose
次要结局
未报告次要终点