Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects
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
The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin 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 metformin 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 metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin 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 metformin or any of the excipients of the formulation of SHR3824 or metformin
研究组 & 干预措施
SHR3824 25mg/metformin 1000mg
Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8.
干预措施: SHR3824 metformin (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 9.
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
The area under the plasma concentration-time curve (AUC) of SHR3824.
时间窗: At protocol-specified times up to Day 9.
AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin.
The maximum plasma concentration (Cmax) of metformin.
时间窗: At protocol-specified times up to Day 9.
Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SHR3824
The area under the plasma concentration-time curve (AUC) of metformin
时间窗: At protocol-specified times up to Day 9.
AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SHR3824.
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability.(Up tp day 9.)