the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cumulative percentage drainage of SP2086 in fecal
研究概览
简要总结
All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
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 any of the excipients of the formulation of SP2086
研究组 & 干预措施
high fat diet
All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately.
干预措施: SP2086 (Drug)
SP2086
All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately.
干预措施: high fat diet (Dietary Supplement)
结局指标
主要结局
Cumulative percentage drainage of SP2086 in fecal
时间窗: up to Day 12
The maximum plasma concentration (Cmax) of SP2086 acid
时间窗: up to Day 12
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 maximum plasma concentration (Cmax) of SP2086
时间窗: up to Day 12
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid
时间窗: up to Day 12
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Cumulative percentage drainage of SP2086 in urine
时间窗: up to Day 12
The area under the plasma concentration-time curve (AUC) of SP2086
时间窗: up to Day 12
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086.
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(up to Day 12)