Patients with type 2 diabetes
Conditions
Interventions
TR group:Inject the test preparation subcutaneously, and inject the reference preparation subcutaneously after three days of washing.
RT group:Subcutaneously inject the reference formulation and subcutaneously inject the test formulation three days after washing.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects ranging in age from 18 to 45 (including threshold) were male and female 2) Male weight =50kg female weight =45 kg, body mass index (BMI) of 18.0~26.0kg/m2 (including the critical value); 3) All fertile subjects agreed to use appropriate and effective physical contraception for themselves and their partners from the screening period to the end of the trial and to use effective physical and/or pharmacological contraception for 3 months after the end of the trial without a pregnancy plan 4) Be able to understand informed consent to participate in this clinical trial voluntarily and sign informed consent 5) Able to follow the study protocol to complete the test
Exclusion criteria
Exclusion criteria: 1) A history of drug or food allergy, known or suspected allergy to the test drug or any of its components; 2) Patients with history of syncope or amaurosis, or history of hypoglycemia, or abnormal fasting blood glucose; 3) Patients with acute or chronic gastrointestinal diseases and disorders of the liver, kidney, endocrine, cardiovascular, neurological, psychiatric, lung, neoplasm, immune, blood, or metabolic disorders or any other disease of clinical significance, or with a history of these diseases that would jeopardize their safety or affect study results, such as: Patients with acute or chronic pancreatitis, medullary thyroid cancer or family history, and multiple endocrine adenomatosis type 2; 4) The results of physical examination, electrocardiogram examination, chest X-ray, laboratory examination (blood routine, urine routine, blood biochemistry, etc.) during the screening period were judged by clinicians as abnormal and clinically significant; 5) Patients with abnormal vital signs (systolic blood pressure 100bpm); 6) During the screening period, the patients who were tested positive for any of the infectious diseases (HIV antigen antibody complex test, treponema pallidum antibody, hepatitis B surface antigen, hepatitis C antibody); 7) Have a history of substance abuse or test positive for urine drugs; 8) People with a history of alcoholism or moderate drinking (moderate drinking is defined as drinking more than three units a day, or more than 21 units a week; A 350ml bottle of beer, 120ml of white wine, 30ml of spirits or 150ml of wine is defined as 1 unit of alcohol consumed); 9) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups of 200ml each) per day; 10) Patients who suffered from serious disease or underwent major surgical operations within 1 year before the first administration of the drug; 11) Smoking more than 5 cigarettes per day in the 3 months before the first dose; 12) Patients who have used the investigational drug or participated in clinical trials of other drugs and administered the drug within 3 months prior to the initial dosing; 13) Those who have donated blood or suffered heavy bleeding (greater than 300ml) within 3 months prior to the first dose, or who plan to donate blood or blood components during the study period or within 1 week after the end of the study; 14) Those who received the vaccine within 3 months before the first dose or plan to receive the vaccine during the study period or within 1 week after the end of the study; 15) A significantly abnormal diet (e.g., diet, low sodium) has begun within 1 month prior to initial administration; 16) Had used any drug within 28 days prior to initial dosing that affected the in vivo safety evaluation of the study drug; 17) Have used any prescription drugs, over-the-counter drugs, Chinese herbs, health products and vitamins within 14 days before the first drug use; 18) Had eaten grapefruit, dragon fruit, mango, broccoli and other food or related products that affect metabolic enzymes within 3 days before the first administration; 19) Ingested any food or drink containing caffeine or xanthine within 48 hours prior to initial administration, such as coffee, strong tea, chocolate, cola, etc.; 20) Smokers within 48 hours before the first dose; 21) Have taken any alcohol-based products wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, PK; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-drug antibody, ADA;Adverse reactions; | — |
Countries
China
Contacts
Public ContactLuo Zhu
West China Hospital, Sichuan University
Outcome results
None listed