A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
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-101 in healthy volunteers
详细描述
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adult aged 19 and more at the time of screening visit
- •Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- •No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination
排除标准
- •Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
- •History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
- •As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range
研究组 & 干预措施
Raloxifene 60mg to AD-101 45mg
Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral
干预措施: AD-101 45mg (Drug)
Raloxifene 60mg to AD-101 45mg
Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral
干预措施: Raloxifene 60mg (Drug)
AD-101 45mg to Raloxifene 60mg
Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral
干预措施: AD-101 45mg (Drug)
AD-101 45mg to Raloxifene 60mg
Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral
干预措施: Raloxifene 60mg (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: pre-dose to 96 hours
Cmax of the total ingredient of AD-101
Area under the curve in time plot (AUCt)
时间窗: pre-dose to 96 hours
AUCt of the total ingredient of AD-101
次要结局
- Time to reach Cmax(pre-dose to 96 hours)
- Effective half-life(pre-dose to 96 hours)
- Area under the curve in time plot (AUCinf)(pre-dose to 96 hours)
- Clearance(pre-dose to 96 hours)
- Volume of distribution(pre-dose to 96 hours)