A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.
详细描述
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.
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
- •Healthy male between 19 and 50 years of age at the time of screening
- •Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2
排除标准
- •Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
- •Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
- •A person who has a history of drug abuse
- •AST, ALT, Total bilirubin values over than 2 times of UNL at screening
- •Creatinine clearance under 80mL/min
研究组 & 干预措施
Sequence 5
Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
干预措施: AD-2102 (Drug)
Sequence 4
Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
干预措施: AD-2101 + AD-2102 (Drug)
Sequence 5
Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
干预措施: AD-2101 (Drug)
Sequence 1
Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
干预措施: AD-2101 (Drug)
Sequence 1
Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
干预措施: AD-2102 (Drug)
Sequence 1
Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
干预措施: AD-2101 + AD-2102 (Drug)
Sequence 2
Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
干预措施: AD-2101 (Drug)
Sequence 2
Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
干预措施: AD-2102 (Drug)
Sequence 2
Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
干预措施: AD-2101 + AD-2102 (Drug)
Sequence 3
Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
干预措施: AD-2101 (Drug)
Sequence 3
Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
干预措施: AD-2102 (Drug)
Sequence 3
Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
干预措施: AD-2101 + AD-2102 (Drug)
Sequence 4
Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
干预措施: AD-2101 (Drug)
Sequence 4
Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
干预措施: AD-2102 (Drug)
Sequence 5
Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
干预措施: AD-2101 + AD-2102 (Drug)
Sequence 6
Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
干预措施: AD-2101 (Drug)
Sequence 6
Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
干预措施: AD-2102 (Drug)
Sequence 6
Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
干预措施: AD-2101 + AD-2102 (Drug)
结局指标
主要结局
Peak Plasma Concentration
时间窗: pre-dose to 24 hours
Cmax,ss of the total ingredient of AD-2101 and AD-2102
Area under the plasma concentration versus time curve
时间窗: pre-dose to 24 hours
AUCt,ss of the total ingredient of AD-2101 and AD-2102
次要结局
- Bottom Plasma Concentration(pre-dose to 24 hours)
- Number of participants with adverse events(From Day 1 up to Day 66)
- Clearance(pre-dose to 24 hours)
- Time to reach Cmax(pre-dose to 24 hours)