NCT04692025已完成1 期
A Randomized, Single Center, Open-label, Phase I Study to Evaluate the Effect of Food and Fasting on the Pharmacokinetics of ASC41 Tablets in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC of ASC41
研究概览
简要总结
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
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
- All
- 接受健康志愿者
- 是
入选标准
- •19kg/m2 ≤ BMI <40kg/m
排除标准
- •A history of thyroid disease.
- •History of, or current liver disease.
研究组 & 干预措施
Group 1
Experimental
ASC41 one tablet, on Day 1 before meal；ASC41 one tablet, on Day 15 after meal.
干预措施: ASC41 tablet (Drug)
Group 2
Experimental
ASC41 one tablet, on Day 1 after meal；ASC41 one tablet, on Day 15 before meal.
干预措施: ASC41 tablet (Drug)
结局指标
主要结局
AUC of ASC41
时间窗: Up to 19 days
Evaluate the Area under the plasma concentration versus time curve after single oral dose of ASC41 administered to healthy volunteers.
Cmax of ASC41
时间窗: Up to 19 days
Evaluate the Peak Plasma Concentration after single oral dose of ASC41 administered to healthy volunteers.
次要结局
- t1/2 of ASC41(Up to 19 days)
- CL/F of ASC41(Up to 19 days)
- Vd/F of ASC41(Up to 19 days)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 19 days)
研究者
研究点 (1)
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