An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of AD-118 Compared to AD-1181 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximum concentration of drug in plasma (Cmax)
研究概览
简要总结
A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult 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 64 Years（Adult）
- 性别
- All
- 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
- •Subjects aged 19 years or older and under 65 years at the 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(AD-1181), Period 2 : Test drug(AD-118)
Single-dose oral administration of AD-1181 in Period 1, followed by single-dose oral administration of AD-118 in Period 2.
干预措施: AD-118, AD-1181 (Drug)
Sequence B
Period 1 : Test drug(AD-118), Period 2 : Reference drug(AD-1181)
Single-dose oral administration of AD-118 in Period 1, followed by single-dose oral administration of AD-1181 in Period 2.
干预措施: AD-118, AD-1181 (Drug)
结局指标
主要结局
Maximum concentration of drug in plasma (Cmax)
时间窗: pre-dose (0hour) to 36hours
Cmax of AD-118
Area under the plasma concentration-time curve during dosing interval (AUCt)
时间窗: pre-dose (0hour) to 36hours
AUCt of AD-118
次要结局
未报告次要终点