The Drug Interaction Study of SP2086 and Valsartan in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The area under the plasma concentration-time curve (AUC) of SP2086 acid
研究概览
简要总结
The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.
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.
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 Valsartan or any of the excipients of the formulation of SP2086 or Valsartan
研究组 & 干预措施
SP2086 and Valsartan
干预措施: SP2086 (Drug)
SP2086 and Valsartan
干预措施: Valsartan (Drug)
结局指标
主要结局
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 Valsartan.
The area under the plasma concentration-time curve (AUC) of Valsartan
时间窗: up to Day 9
AUC (a measure of the body's exposure to Valsartan) will be compared before and after administration of multiple doses of SP2086
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 Valsartan
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 Valsartan
The maximum plasma concentration (Cmax) of Valsartan
时间窗: up to Day 9
Cmax (a measure of the body's exposure to Valsartan) 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 Day 9
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Valsartan.
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(up to Day 9)