The Drug Interaction Study of SP2086 and Simvastatin 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 maximum plasma concentration (Cmax) of SP2086
研究概览
简要总结
The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.
详细描述
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SP2086 and Simvastatin in healthy adult volunteers. SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
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 metformin or any of the excipients of the formulation of SP2086 or Simvastatin
研究组 & 干预措施
SP2086 and Simvastatin
SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
干预措施: SP2086 (Drug)
SP2086 and Simvastatin
SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
干预措施: Simvastatin (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 Simvastatin.
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 Simvastatin.
The maximum plasma concentration (Cmax) of Simvastatin
时间窗: up to Day 9
Cmax (a measure of the body's exposure to Simvastatin) 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 Simvastatin.
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 Simvastatin.
The area under the plasma concentration-time curve (AUC) of Simvastatin
时间窗: up to Day 9
AUC (a measure of the body's exposure to Simvastatin) 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)