The Drug-drug Interaction of SP2086 and Metformin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- The maximum plasma concentration (Cmax) of SP2086
研究概览
简要总结
This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin.
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 26 kg/m2,weight among of 50-100kg.
- •willing to using contraception during the study and after the 6 months.
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 SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin
研究组 & 干预措施
SP2086 and Metformin
In the first day,the subject takes metformin 1000mg once,and from Day 4 to Day 7 they need to take SP2086 100mg everyday. In Day 8,they will be given SP2086 100mg and metformin 1000mg.
干预措施: SP2086 (Drug)
SP2086 and Metformin
In the first day,the subject takes metformin 1000mg once,and from Day 4 to Day 7 they need to take SP2086 100mg everyday. In Day 8,they will be given SP2086 100mg and metformin 1000mg.
干预措施: Metformin (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of SP2086
时间窗: up to Day 9
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
The area under the plasma concentration-time curve (AUC) of SP2086
时间窗: up to Day 9
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of metformin
The maximum plasma concentration (Cmax) of SP2086 acid
时间窗: up to Day 9
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
The area under the plasma concentration-time curve (AUC) of SP2086 acid
时间窗: up to Day 9
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of metformin
The maximum plasma concentration (Cmax) of Metformin
时间窗: 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 SP2086
The area under the plasma concentration-time curve (AUC) of metformin
时间窗: 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 SP2086
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(up to Day 9)