NCT07722871尚未招募1 期
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions
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
- 44
- 试验地点
- 1
- 主要终点
- 1. Area under the plasma concentration-time curve during dosing interval (AUCt)
研究概览
简要总结
This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight equal to or greater than 50 kg and body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- •Age equal to or greater than 19 years in healthy adult male volunteers at the time of screening visit
排除标准
- •Participation in another clinical study with an investigational drug within 6 months prior to the scheduled first administration
- •Other exclusions applied
结局指标
主要结局
1. Area under the plasma concentration-time curve during dosing interval (AUCt)
时间窗: [Time Frame: pre-dose (0hour) to 48hours]
AUCt of AD-116A
次要结局
- 2. Maximum concentration of drug in plasma (Cmax)([Time Frame: pre-dose (0hour) to 48hours])
研究者
研究点 (1)
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