A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) to last time point (t)
研究概览
简要总结
The purpose of this study is Safety, Pharmacokinetic Study of PRIC
详细描述
- To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
- To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19 to 45 years old healthy male subject at the screening
- •Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study
排除标准
- •Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions
研究组 & 干预措施
A group
Period 1: PRIC Period 2: Pranlukast hydrate
干预措施: PRIC (Drug)
A group
Period 1: PRIC Period 2: Pranlukast hydrate
干预措施: Pranlukast hydrate (Drug)
B group
Period 1: Pranlukast hydrate Period 2: PRIC
干预措施: PRIC (Drug)
B group
Period 1: Pranlukast hydrate Period 2: PRIC
干预措施: Pranlukast hydrate (Drug)
结局指标
主要结局
Area Under the Curve (AUC) to last time point (t)
时间窗: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final
Maximum concentration of drug (Cmax)
时间窗: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t
次要结局
未报告次要终点