A Single Randomized, Open,Cross-over, Phase I Study to Access the Drug-drug Interaction of SP2086 and Valsartan
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 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 SP2086 and Valsartan after multiple oral doses treatment 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 and cross-over study of SP2086 and Valsartan in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences, all subjects must completed the two stages(A and B). The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages. The whole study needs 31 days.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2
- •Had signed the informed consent himself or herself.
排除标准
- •Have the abnormal lab or other examination results and the change have clinical significance.
- •History of or current clinically significant medical illness as determined by the Investigator.
- •Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome
- •Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide.
- •History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs.
- •History of severe unconsciousness hypoglycemia
- •History of any surgery prior to screening in 6 months.
- •History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month.
- •History of participate any drug or medical device prior to screening in 3 months.
- •Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins).
- •2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion.
- •The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive.
- •Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
- •Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
研究组 & 干预措施
SP2086 and Valsartan
All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from A stage to B stage.
干预措施: SP2086 (Drug)
SP2086 and Valsartan
All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from A stage to B stage.
干预措施: Valsartan (Drug)
Valsartan and SP2086
All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from B stage to A stage.
干预措施: SP2086 (Drug)
Valsartan and SP2086
All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages.The whole study needs 31 days.This group patient was given treatment from B stage to A stage.
干预措施: Valsartan (Drug)
结局指标
主要结局
The maximum plasma concentration (Cmax) of SP2086
时间窗: up to Day 31
Cmax (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 31
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 valsartan
时间窗: up to Day 31
Cmax (a measure of the body's exposure to valsartan) will be compared before and after administration of multiple doses of valsartan
The area under the plasma concentration-time curve (AUC) of SP2086
时间窗: up to Day 31
AUC (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 Day 31
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 valsartan
时间窗: up to Day 31
AUC (a measure of the body's exposure to valsartan) will be compared before and after administration of multiple doses of valsartan
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(up to Day 31)