Drug Interaction Study of Henagliflozin and Retagliptin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The area under the plasma concentration-time curve (AUC) of SHR3824.
研究概览
简要总结
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and multiple oral doses of SP2086 in healthy adult volunteers.
详细描述
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and SP2086 in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) ,and SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18. Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.
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 volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 kg/m2.
排除标准
- •History of diabetes
- •History of heart failure or renal insufficiency,Urinary tract infections, or vulvovaginal mycotic infections
- •History of or current clinically significant medical illness as determined by the Investigator
- •History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- •Known allergy to SHR3824 or SP2086 or any of the excipients of the formulation of SHR3824 or SP2086
研究组 & 干预措施
SHR3824 20mg/SP2086 100mg
One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.
干预措施: SHR3824, SP2086 (Drug)
结局指标
主要结局
The area under the plasma concentration-time curve (AUC) of SHR3824.
时间窗: At protocol-specified times up to Day 14 and Day 18.
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
The maximum plasma concentration (Cmax) of SHR3824.
时间窗: At protocol-specified times up to Day 14 and Day 18.
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
The maximum plasma concentration (Cmax) of SP2086.
时间窗: At protocol-specified times up to Day 4 and Day 18.
Cmax (a measure of the body's exposure to SP2086) will be compared. before and after administration of multiple doses of SHR3824
The area under the plasma concentration-time curve (AUC) of SP2086.
时间窗: At protocol-specified times up to Day 4 and Day 18.
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SHR3824.
The number of volunteers with adverse events as a measure of safety and tolerability.
时间窗: Up tp day 18.
次要结局
未报告次要终点