An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •signed the informed consent form prior to the study participation
排除标准
- •Clinically significant disease
- •Previously donate whole blood within 2 months or component blood within 1 month
- •Clinically significant allergic disease
- •Taken IP in other trial within 3 months
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result
研究组 & 干预措施
RT group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
干预措施: DP-R213 (Drug)
RT group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
干预措施: Raloxifene (Drug)
RT group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
干预措施: Cholecaliferol (Drug)
TR group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
干预措施: DP-R213 (Drug)
TR group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
干预措施: Raloxifene (Drug)
TR group
combination dose of Raloxifene and Cholecaliferol and DP-R213 in order
干预措施: Cholecaliferol (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: up to 96 hours post dose
Peak Plasma Concentration (Cmax)
时间窗: up to 96 hours post dose
次要结局
未报告次要终点