A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve(AUCt) of raloxifene
研究概览
简要总结
The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy male volunteer, age above 19
- •The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20%
- •Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study
- •Treatment history of other drugs within last 10 days
研究组 & 干预措施
Group C
B → A → C
干预措施: Cholecalciferol and Raloxifene co-administration (Drug)
Group A
A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene
干预措施: Cholecalciferol (Drug)
Group A
A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene
干预措施: Raloxifene (Drug)
Group A
A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene
干预措施: Cholecalciferol and Raloxifene co-administration (Drug)
Group B
A → C → B
干预措施: Cholecalciferol (Drug)
Group B
A → C → B
干预措施: Raloxifene (Drug)
Group B
A → C → B
干预措施: Cholecalciferol and Raloxifene co-administration (Drug)
Group C
B → A → C
干预措施: Cholecalciferol (Drug)
Group C
B → A → C
干预措施: Raloxifene (Drug)
Group D
B → C → A
干预措施: Cholecalciferol (Drug)
Group D
B → C → A
干预措施: Raloxifene (Drug)
Group D
B → C → A
干预措施: Cholecalciferol and Raloxifene co-administration (Drug)
Group E
C → A → B
干预措施: Cholecalciferol (Drug)
Group E
C → A → B
干预措施: Raloxifene (Drug)
Group E
C → A → B
干预措施: Cholecalciferol and Raloxifene co-administration (Drug)
Group F
C → B → A
干预措施: Cholecalciferol (Drug)
Group F
C → B → A
干预措施: Raloxifene (Drug)
Group F
C → B → A
干预措施: Cholecalciferol and Raloxifene co-administration (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve(AUCt) of raloxifene
时间窗: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
Peak plasma concentration(Cmax) of raloxifene
时间窗: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
AUCt,corr of cholecalciferol
时间窗: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Cmax,corr of cholecalciferol
时间窗: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
次要结局
未报告次要终点