NCT07717775尚未招募1 期
A Randomized, Open-label, 6-sequence, 3-period Crossover Clinical Trial to Compare the Pharmacokinetic, Pharmacodynamic and Safety/Tolerability Characteristics Following Multiple Oral Administration of AD-234, AD-2341, and AD-2342 in Healthy Adult Volunteers.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose
研究概览
简要总结
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-234, AD-2341, AD-2342 in healthy subjects.
详细描述
The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-234 compared with AD-2341, AD-2342 in healthy 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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening
- •Body weight between 50.0 kg and 90.0 kg, inclusive, and body mass index (BMI) between 18.5 kg/m^2 and 29.9 kg/m^2, inclusive, at the time of screening (BMI = weight [kg] / height [m]^2)
- •For female participants: not pregnant, not breastfeeding, or surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
排除标准
- •Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration Other exclusions applied
结局指标
主要结局
Percent of Time With Gastric pH ≥4 During the 24-hour Interval After the 7th Dose
时间窗: From pre-dose (0h) on Day 7 to 24 hours post-dose on Day 7 of each treatment period (Period 1: Day 7-Day 8; Period 2: Day 28-Day 29; Period 3: Day 49-Day 50)
次要结局
未报告次要终点
研究者
研究点 (1)
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