A Randomized, Open-label, Single-dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of AD-115A and the Administration of AD-1151 for Healthy Subjects in Fasting State
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Maximum concentration of drug in plasma (Cmax)
研究概览
简要总结
The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.
详细描述
A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state
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
- 否
入选标准
- •The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
- •Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
排除标准
- •Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
- •Other exclusions applied
研究组 & 干预措施
Sequence B
Period 1 : Test Drug(Revaprazan sulfate), Period 2 : Reference Drug(Rebanex Tab)
Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2.
干预措施: AD-115A, AD-1151 (Drug)
Sequence A
Period 1 : Reference Drug(Rebanex Tab), Period 2 : Test Drug(Revaprazan sulfate)
Single-dose oral administration of AD-115A (200 mg tablet) in Period 1, followed by single-dose oral administration of AD-1151 (200 mg tablet) in Period 2.
干预措施: AD-115A, AD-1151 (Drug)
结局指标
主要结局
Maximum concentration of drug in plasma (Cmax)
时间窗: pre-dose to 24 hours
Cmax of AD-115A
Area under the plasma concentration-time curve during dosing interval (AUCt)
时间窗: pre-dose to 24 hours
AUCt of AD-115A
次要结局
未报告次要终点