Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 主要终点
- The maximum plasma concentration (Cmax) of SHR3824
研究概览
简要总结
the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2
排除标准
- •History of hypoglycemia
- •History of urinary tract infections,or genital infections
- •History of current clinically significant medical illness as determined by the Investigator
- •Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin
研究组 & 干预措施
SHR3824 1Omg,Simavastatin 40mg
two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.
干预措施: SHR3824, Simvastatin (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of SHR3824
时间窗: At protocol-specified times up to Day 7 and Day 8
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
The area under the plasma concentration-time curve (AUC) of SHR3824
时间窗: At protocol-specified times up to Day 7 and Day 8
AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .
时间窗: At protocol-specified times up to Day 1 and Day 8
AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 .
The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.
时间窗: At protocol-specified times up to Day 1 and Day 8
Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin .
The number of volunteers with adverse events as a measure of safety and tolerability.
时间窗: up to day 15
次要结局
未报告次要终点