An Open-label, Two-period, One-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 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-2071 and AD-2072 in healthy male volunteers.
详细描述
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2071 and AD-2072.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2
排除标准
- •Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric
- •Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
- •HDL values less than 35 mg/dL
- •AST, ALT values over than 1.5 times of ULN at screening
- •A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test
研究组 & 干预措施
Sequence 1
Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
干预措施: AD-2071 10/20mg (Drug)
Sequence 1
Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
干预措施: AD-2072 80/5mg (Drug)
Sequence 1
Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
干预措施: AD-2071 10/20mg + AD2072 80/5mg (Drug)
结局指标
主要结局
Peak Plasma Concentration
时间窗: pre-dose to 24 hours
Cmax of the total ingredient of AD-2071 and AD-2072
Area under the plasma concentration versus time curve
时间窗: pre-dose to 24 hours
AUCtau of the total ingredient of AD-2071 and AD-20172
次要结局
- Elimination half-life(pre-dose to 24 hours)
- Time to reach Cmax(pre-dose to 24 hours)
- Number of participants with adverse events(From Day 1 up to Day 46)
- Clearance(pre-dose to 24 hours)
- Volume of distribution(pre-dose to 24 hours)