A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- AUCtau,ss(Area under the plasma drug concentration-time curve)
研究概览
简要总结
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.
详细描述
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole 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
- •Age 19~50 years in healthy male volunteers
- •BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2
- •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Group A1
Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)
干预措施: AD-206 20mg (Drug)
Group B1
Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)
干预措施: Esomeprazole 40mg (Drug)
Group A1
Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg)
干预措施: Esomeprazole 20mg (Drug)
Group A2
Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)
干预措施: AD-206 20mg (Drug)
Group A2
Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg)
干预措施: Esomeprazole 20mg (Drug)
Group B1
Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg)
干预措施: AD-206 40mg (Drug)
Group B2
Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)
干预措施: AD-206 40mg (Drug)
Group B2
Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg)
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
AUCtau,ss(Area under the plasma drug concentration-time curve)
时间窗: From Day 1 up to Day 29
Evaluation PK esomeprazole after multiple dose
Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)
时间窗: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring
Evaluation PD esomeprazole after multiple dose
次要结局
- AUCtau(Area under the plasma drug concentration-time curve)(Day1)
- Cmax(Maximum concentration of drug in plasma)(Day1)
- Tmax(Time to maximum plasma concentration)(Day1)
- t1/2(Terminal elimination half-life)(Day1)
- CL/F(Apparent clearance)(Day1)
- Vd/F(Apparent volume of distribution)(Day1)
- Cmax,ss(Maximum concentration of drug in plasma at steady state)(From Day 1 up to Day 29)
- Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)(From Day 1 up to Day 29)
- Cav,ss(Average concentration of drug in plasma at steady state)(From Day 1 up to Day 29)
- Tmax,ss(Time to maximum plasma concentration at steady state)(From Day 1 up to Day 29)
- t1/2,ss(Terminal elimination half-life at steady state)(From Day 1 up to Day 29)
- CLss/F(Apparent Clearance at steady state)(From Day 1 up to Day 29)
- Vss/F(Apparent Volume of distribution at steady state)(From Day 1 up to Day 29)
- PTF(Peak trough fluctuation over one dosing interal at steady state)(From Day 1 up to Day 29)
- After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours(Day1 24hrs pH monitoring)
- After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours(Day1 24hrs pH monitoring, Day7 24hrs pH monitoring)
- After the first administration and 7 days of repeated administration, The median pH measured for 24 hours(Day1 24hrs pH monitoring, Day7 24hrs pH monitoring)