A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects
详细描述
This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- •The Age between 19 and 50 in healthy male volunteers at the time of screening visit
排除标准
- •As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range
- •As a result of laboratory tests, the following figures: 25-OH vitamin D total <9 ng/mL
研究组 & 干预措施
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
干预措施: Raloxifene 60mg/Cholecalciferol 800IU (Drug)
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
干预措施: AD-102 (Drug)
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
干预措施: Raloxifene 60mg/Cholecalciferol 800IU (Drug)
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
干预措施: AD-102 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: pre-dose to 72 hours
Cmax of corrected Cholecalciferol
Area under the curve in time plot (AUCt)
时间窗: pre-dose to 72 hours
AUCt of corrected Cholecalciferol
次要结局
- Effective half-life(pre-dose to 72 hours)
- Time to reach Cmax(pre-dose to 72 hours)
- Area under the curve in time plot (AUCinf)(pre-dose to 72 hours)