An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Period Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult 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 —（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
Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.
干预措施: AD-116, AD-1161 (Drug)
Sequence B
Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2.
干预措施: AD-116, 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