Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)
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 SHR3824
研究概览
简要总结
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.
详细描述
This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a body mass index(BMI) between 19 and 33 Kg/m2;
- •The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m
- •Had signed the informed consent himself or herself voluntarily.
排除标准
- •Urinary tract infections, or vulvovaginal mycotic infections
- •Suspected or diagnosed as kidney cancer or other malignancies in patients
- •Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated
- •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 SHR3824,SGLT2 inhibitor analogs, or any other structural analogs
- •Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.
- •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
Normal renal function
All subjects were given SHR3824 20mg only one time.
干预措施: SHR3824 (Drug)
Mild renal dysfunction
All subjects were given SHR3824 20mg only one time.
干预措施: SHR3824 (Drug)
Moderate renal dysfunction
All subjects were given SHR3824 20mg only one time.
干预措施: SHR3824 (Drug)
结局指标
主要结局
The area under the plasma concentration-time curve (AUC) of SHR3824
时间窗: 72 hours after dosing
AUC (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients
The maximum plasma concentration (Cmax) of SHR3824
时间窗: 72 hours after dosing
Cmax (a measure of the body's exposure to SHR3824) will be compared between normal renal function patients and mild or moderate renal dysfunction patients
次要结局
- The number of volunteers with adverse events as a measure of safety and tolerability(72 hours after dosing)