NCT07103278已完成1 期
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve during dosing interval (AUCt)
研究概览
简要总结
The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers
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 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- •The Age equal to or greater than 19 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 the 6 months from scheduled first administration
- •Other exclusions applied
研究组 & 干预措施
Sequence A
Experimental
Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116)
干预措施: AD-116 (Drug)
Sequence A
Experimental
Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116)
干预措施: AD-1161 (Drug)
Sequence B
Experimental
Period 1 : Test Drug(AD-116), Period 2 : Reference Drug(AD-1161)
干预措施: AD-116 (Drug)
Sequence B
Experimental
Period 1 : Test Drug(AD-116), Period 2 : Reference Drug(AD-1161)
干预措施: AD-1161 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve during dosing interval (AUCt)
时间窗: pre-dose (0hour) to 72hours
AUCt of AD-116
Maximum concentration of drug in plasma (Cmax)
时间窗: pre-dose (0hour) to 72hours
Cmax of AD-116
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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