A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-2321 and AD-2322 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
研究概览
简要总结
To evaluate the pharmacokinetic interactions of AD-2321, AD-2322 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthy adult volunteers aged ≥19 and <65 years at the time of the screening visit
- •Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of 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
Arm A
Period 1 : Treatment A(AD-2321), Period 2 : Treatment C(AD-2321+AD-2322)
干预措施: Treatment A(AD-2321) (Drug)
Arm A
Period 1 : Treatment A(AD-2321), Period 2 : Treatment C(AD-2321+AD-2322)
干预措施: Treatment C(AD-2321+AD-2322) (Drug)
Arm B
Period 1 : Treatment B(AD-2322), Period 2 : Treatment C(AD-2321+AD-2322)
干预措施: Treatment B(AD-2322) (Drug)
Arm B
Period 1 : Treatment B(AD-2322), Period 2 : Treatment C(AD-2321+AD-2322)
干预措施: Treatment C(AD-2321+AD-2322) (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
时间窗: pre-dose (0hour) to 24 hours post-dose on Day 14
AUCτ,ss
Maximum concentration of drug in plasma at steady state (Cmax,ss)
时间窗: pre-dose (0hour) to 24 hours post-dose on Day 14
次要结局
未报告次要终点