diabetes
Conditions
Interventions
1:TRR
2:RTR
3:RRT
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Participate in the trial and sign the informed consent form (ICF) voluntarily; 2) Healthy Chinese male subjects 18-45 years old (including 18 and 45 years old); 3) Body mass index [BMI = weight (kg) / height (m) 2] during screening: 19.0-24.0 kg/m2, including 19.0 and 24.0 kg/m2; 4) Weight >=50.0 kg; 5) No family history of obesity and diabetes; 6) Normal glucose tolerance: [3.9 mmol/L (70.2 mg/dL) <fasting blood glucose <6.1 mmol/L (101 mg/dL), and 2-hour postprandial blood glucose of oral glucose tolerance test (OGTT) <7.8 mmol/L ( 140 mg/dL)]; 7) There is sufficient venous access, so that blood collection channels can be established according to the research plan; 8) There is no birth plan during the study period, and it is agreed to use reliable contraception during the study period until 6 months after the last administration of the experimental drug, and there is no sperm donation plan; 9) Able to communicate well with researchers and complete research in accordance with research regulations.
Exclusion criteria
Exclusion criteria: 1. At the time of screening, with a history of heart, liver, kidney, digestive tract, nervous system diseases and metabolic abnormalities (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiac Cerebrovascular disease); 2. According to the judgment of the investigator at the time of screening, there are abnormal and clinically significant vital signs, physical examination results, laboratory examination results, chest radiograph results and 12-lead electrocardiogram results; 3) Have a history of hypoglycemia within 3 months before screening; 4) Those who have had a serious infection or trauma within 4 weeks before screening or have undergone surgery within 3 months before screening; 5) Known severe allergies (such as allergies to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergies requiring glucocorticoid therapy) or known allergies to the test drug components of this study; 6) Any drugs that affect insulin's hypoglycemic effect (such as corticosteroids, danazol, diazoxide, diuretics, epinephrine, salbutamol, terbutaline, glucagon, growth hormone, etc.) were used within 4 weeks before screening , Thyroid hormones, ß-blockers), etc.; 7) The test results of hepatitis B surface antigen (HBsAg) and syphilis non-specific antibodies are positive, and the test results of human immunodeficiency virus antibodies (Anti-HIV), hepatitis C virus antibodies (Anti-HCV), and syphilis specific antibodies are >=1.0 person; 8) Those who have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, and health products (except regular vitamin supplements) within 2 weeks before screening (except for three drugs such as contraceptives, estrogen and progesterone used in stable doses more than 2 months before screening); 9) People who donated blood >=200 mL within 6 months before screening, or donated blood of any component, or caused total blood loss >=200 mL for any reason, or have a history of blood transfusion or blood product use; 10) Any type of anemia judged by researcher (male: hemoglobin 0 mg/100mL); 13) People who have a history of drug abuse or illicit drugs (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, tetrahydrocannabinol acid) during screening within 6 months before screening have a positive urine test. 14) Those who have had major changes in diet or exercise habits within 3 months before screening; 15) Those who have participated in other clinical trials (drugs or medical devices, randomized and used investigational drugs or medical devices) 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; 16) Those who have any food allergies or special dietary requirements and cannot follow a unified diet (such as intolerance to standard meals, intolerance to lactose, etc.); 17) People who have a history of fainting needles and blood, cannot tolerate venipunct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed