Pharmacokinetics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The steady-state urine concentration (Css) of SP2086
研究概览
简要总结
SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of SP2086 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI(a measure of a person's weight in relation to height)is between 19 and 26 kg/m2,and the weight is equal or less than 100kg.
- •without the history of cardiovascular diseases,liver diseases,kidney diseases,gastrointestinal tract diseases,mental nerve diseases and drug allergy.
- •Be willing to accept physical contraception.
- •Sign the informed consents voluntarily and ensure to completed the study.
排除标准
- •Known allergy to SP2086 or any of the excipients of the formulation of SP2086;
- •ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.
- •the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.
- •had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.
- •have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.
- •have the history of tobacco,alcohol or drug abuse.
- •History of or current clinically significant medical illness as determined by the Investigator.
研究组 & 干预措施
SP2086 50mg
there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.
干预措施: SP2086 (Drug)
SP2086 100mg
there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.
干预措施: SP2086 (Drug)
SP2086 200mg
there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.
干预措施: SP2086 (Drug)
结局指标
主要结局
The steady-state urine concentration (Css) of SP2086
时间窗: up to Day 13
Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The maximum urine concentration (Cmax) of SP2086
时间窗: up to Day 13
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The maximum plasma concentration (Cmax) of SP2086
时间窗: up to Day 13
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086.
The maximum urine concentration (Cmax) of SP2086 acid
时间窗: up to Day 13
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086
The steady-state urine concentration (Css) of SP2086 acid
时间窗: up to Day 13
Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
Cumulative excretion of SP2086
时间窗: up to Day 13
The steady-state plasma concentration (Css) of SP2086
时间窗: up to Day 13
Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid
时间窗: up to Day 13
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
The steady-state plasma concentration (Css) of SP2086 acid
时间窗: up to Day 13
Css (a measure of the body's exposure to SP2086 acid) 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 13)