An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Maximum concentration of drug in plasma (Cmax)
研究概览
简要总结
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
详细描述
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy 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
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight equal to or greater than 50kg (Female 45kg) 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 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 (RT)
Period 1: Reference (PA-111A), Period 2: Test (PA-111)
干预措施: PA-111 (Drug)
Sequence A (RT)
Period 1: Reference (PA-111A), Period 2: Test (PA-111)
干预措施: PA-111A (Drug)
Sequence A (TR)
Period 1: Test (PA-111), Period 2: Reference (PA-111A),
干预措施: PA-111 (Drug)
Sequence A (TR)
Period 1: Test (PA-111), Period 2: Reference (PA-111A),
干预措施: PA-111A (Drug)
结局指标
主要结局
Maximum concentration of drug in plasma (Cmax)
时间窗: pre-dose (0hour) to 72hours
Cmax of PA-111
Area under the plasma concentration-time curve during dosing interval (AUCt)
时间窗: pre-dose (0hour) to 72hours
AUCt of PA-111
次要结局
未报告次要终点