A Single-center, Randomized, Open, Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- The maximum plasma concentration (Cmax) of SP2086 acid
研究概览
简要总结
The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.
详细描述
All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.
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) between 19 and 25 Kg/m2,and weight ≥50kg.
- •Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
- •Had signed the informed consent himself or herself voluntarily.
排除标准
- •Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
- •Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
- •The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
- •Did not take effective contraceptive measures or planning of the subjects in half a year.
- •Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.
研究组 & 干预措施
SP2086
SP2086 was taken only one time at 100mg dose in health volunteers
干预措施: SP2086 (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of SP2086 acid
时间窗: up to 96 hours
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086
时间窗: up to 96 hours
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid
时间窗: up to 96 hours
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086
时间窗: up to 96 hours
AUC (a measure of the body's exposure to SP2086) 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 96 hours)