A Dose-block Randomized, Active-controlled, Open-label Clinical Study to Compare Pharmacokinetic Property of SYO-1644 Tab and Nexavar Tab in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evaluation of pharmacokinetic properties
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability, and safety after orally administrating SYO-1644 to healthy male volunteers in randomized, active-controlled, open-label clinical study.
详细描述
After orally administrating SYO-1644 and Nexavar 200 mg to healthy male participants , the safety, tolerability, and pharmacokinetic characteristics are to be compared while testing pharmacokinetic characteristics based on the dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male age between 19 and 50 years old at the time of screening
- •Healthy male more than or equal to 50 kg or less than or equal to 90 kg with BMI of 18~27
- •BMI(kg/m2) = Weight(kg) / {Height(m)}2
- •Agreement with written informed consent
排除标准
- •Participants with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary, psychiatric disorders or history
- •Participants with history of gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc, that may affect the safety and pharmacokinetic evaluation of the test drug, except simple appendectomy and hernia surgery)
- •Participants with hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sorafenib and allogeneic drugs, and other drugs (aspirin, antibiotics, etc.)
研究组 & 干预措施
SYO-1644 100mg
SYO-1644 tablet, PO, 1 100mg tablet
干预措施: SYO-1644 (Drug)
SYO-1644 150mg
SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet
干预措施: SYO-1644 (Drug)
SYO-1644 200mg
SYO-1644 tablet, PO, 2 100mg tablet
干预措施: SYO-1644 (Drug)
Nexavar
Nexavar 200mg/tablet, PO, 1 tablet
干预措施: Nexavar tab (Drug)
结局指标
主要结局
Evaluation of pharmacokinetic properties
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
Pharmacokinetics of the Cmax between SYO-1644 and Nexavar cap(200mg)
次要结局
未报告次要终点