NCT04975022已完成1 期
Research on Clinical Application of New Therapies for Diabetes and Its Complications and Related Translational Medicine Research
Beijing Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年12月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC 0-8 h
研究概览
简要总结
The objective of this study was to preliminarily verify whether the oral insulin N11005 is a prandial insulin by assessing the PK, PD, and safety profiles of N11005.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Volunteer to participate in the trial and sign an informed consent form; 2) 18-45 years old (including 18 and 45 years old) healthy male subjects (without heart, liver, kidney, digestive tract, neurological diseases, and metabolic abnormalities in the 4 weeks before screening; No abnormal clinically significant vital signs results, physical examination results, laboratory examination results and electrocardiogram examination results judged by the investigator at the time of screening); 3) BMI (body mass index): between 19-24 Kg/m2, including 19 and 24 Kg/m2; 4) Normal glucose tolerance (fasting plasma glucose [FPG] <6.1 mmol/L, and oral glucose tolerance test [OGTT] 2-hour postprandial blood glucose <7.8 mmol/L); 5) No family history of diabetes, obesity, etc.; 6) Insulin secretion function is normal (confirmed by insulin release test (IRT) judged by the investigator); 7) There is no planned parenthood during the study period, and it is agreed to use reliable contraceptive measures during the study period until 4 weeks after the last administration of the study drug; 8) Be able to communicate well with researchers and complete research in accordance with research regulations.
排除标准
- •. Those who have serious systemic diseases, infectious diseases or mental disorders; 2). The results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, syphilis test are positive; 3). Those who have used any prescription drugs, Chinese herbal medicines and/or over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol) and health products (except routine vitamin supplements) within 2 weeks before screening; 4). Those who donated more than 400 mL of blood within 3 months before screening; 5). Severe smokers (25 or more cigarettes per day); 6). Alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who have a positive alcohol breath test result; 7). Those who have a history of drug abuse or have a positive urine test for illegal drugs; 8). Those who are known or suspected to be allergic to insulin and/or its excipients; 9). Those who have participated in other clinical trials within 3 months before screening, or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial; 10). Those who have any food allergies or have special dietary requirements and cannot follow a unified diet; 11). Those who have undergone gastrointestinal surgery before screening, or have a history of gastric obstruction or impaired gastrointestinal motility; 12). Those who are using gastric mucosal protective agents during screening; 13). Those who are deemed unsuitable to participate in this trial after the researcher's evaluation;
研究组 & 干预措施
T group
Experimental
干预措施: N11005 (Drug)
R group
Active Comparator
干预措施: Novolin R (Drug)
结局指标
主要结局
AUC 0-8 h
时间窗: Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；
the AUC for insulin from time zero to 8 hours
Cmax
时间窗: Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；
the peak concentration
AUCGIR,0-8 h
时间窗: Pre-dose, 0-8 hours
GIRmax
时间窗: Pre-dose, 0-8 hours
次要结局
- Tmax(Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300,330,360,420,480 minutes；)
- AUC 0-2 h(Pre-dose, 5,10,20,30,40,50,60,75,90,105,120 minutes)
- the elimination half-life (t1/2) of serum insulin(Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；)
- the AUC for insulin from time zero to 4 h(Pre-dose, 5,10,20,30,40,50,60,75,90,105,120,150,180,210,240 minutes)
- the AUC for insulin from time zero to infinite time(Pre-dose, 5,10,20,30,45,10,20,30,40,50,60,75,90,105,120,150,180,210,240,270,300, 330,360,420,480 minutes；)
- AUCGIR，0-2 h(Pre-dose, 0-2 hours)
- AUCGIR，0-4 h(Pre-dose, 0-4 hours)
- tGIRmax(Pre-dose, 0-8 hours)
研究者
研究点 (1)
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