An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- The maximum plasma concentration (Cmax) of SHR3824
研究概览
简要总结
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 18-25 kg/m2.
排除标准
- •History of clinically significant illness.
- •History of alcohol or drug abuse.
研究组 & 干预措施
SHR3824 10mg fasted to fed
SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3.
干预措施: SHR3824 (Drug)
SHR3824 10mg fed to fasted
SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3.
干预措施: SHR3824 (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of SHR3824
时间窗: Day 1-4 on visit 2 and visit 3
Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
The area under the plasma concentration-time curve (AUC) of SHR3824
时间窗: Day 1-4 on visit 2 and visit 3
AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
The accumulative excretion rate of SHR3824 and its metabolites in urine and feces
时间窗: Day 1-4 on visit 2 and visit 3
Accumulative excretion rate will be compared under fating state and fasted state
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability.(Up to Day 12)