A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
试验速览
- 阶段
- 1 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
研究概览
简要总结
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a body mass index ≥18 and ≤30 kg/m2;
- •Screening sUA value ≥8mg/dl;
- •Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
排除标准
- •Subject known or suspected of being sensitive to the study drugs or its ingredient；
- •ALT、AST、TBIL>ULN;
- •History of kidney stones or screening kidney stones by B-ultrasound；
- •History of malignancy；
- •History of xanthinuria；
- •Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。
研究组 & 干预措施
SHR4640
SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
干预措施: SHR4640 dose1 (Drug)
SHR4640
SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.
干预措施: Febuxostat dose2 (Drug)
Febuxostat
Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd.
干预措施: SHR4640 dose1 (Drug)
Febuxostat
Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd.
干预措施: Febuxostat dose2 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
时间窗: Day1 to Day 14
Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
时间窗: Day1 to Day 14
次要结局
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events(Clinical significant changes from Day-21 up to Day 29)
- Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma(Day1 to Day 14)