Type II diabetes
Conditions
Interventions
The first group:Single subcutaneous injection of Liraglutide injection (reference preparation), Liraglutide injection (test preparation)
The second group:Single subcutaneous injection of Liraglutide injection (test preparation), Liraglutide injection (reference preparation)
Sponsors
West China Second Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 60 (including 18 and 60), male and female; 2) Male body weight >= 50.0kg, female body weight >= 45.0 kg;The body mass index (BMI) was in the range of 19-26 kg/m2 (including the critical value); 3) Cardiovascular, respiratory, renal, gastrointestinal, liver, metabolic, endocrine, immune, neurological or psychiatric diseases of no clinical significance; 4) All examinations were completed and the results were within the normal range for age and sex, or were in line with protocol, or were abnormally non-clinically significant (NCS); 5) Agree to take physical contraceptive measures during the study period, and have no fertility plan for at least 6 months after drug administration in the last study, voluntarily take effective contraceptive measures and have no sperm and egg donation plan; 6) The subjects can communicate well with the researchers, understand and abide by the requirements of this study, and understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Type II multiple endocrine neoplasia syndrome (MEN2) or family history of medullary thyroid carcinoma (MTC); 2. A history of pancreatitis; 3. Have a history of gallbladder-related diseases; 4. People who are known or suspected to be allergic to this product or GLP-1 drugs, and people with high allergy; 5. Use prescription drugs 14 days before use of the study drug, use any over-the-counter or prescription drugs, Chinese patent medicine products 3 days before use of the study drug; 6. Any drugs or inducers that inhibit or induce liver drug metabolism enzymes, such as rifampicin, barbiturates, carbamazepine, phenytoin, glucocorticoids, and omeprazoles, were used in the 30 days before the experiment;Inhibitors such as SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; 7. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, syphilis antibody (TP-TRUST) test results are positive; 8. Have a history of alcohol abuse in the 6 months prior to the study, such as drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL 40% spirit or 150mL wine), or have a positive breath test result; 9. Smoke >= 5 cigarettes per day and cannot stop using any tobacco products during the study period; 10. Drinking too much strong tea, espresso and/or caffeinated beverages every day; 11. Ingestion of chocolate or any food or beverage containing caffeine, theophylline, theobromine or alcohol within 48 hours before use of the study drug; 12. Those who have consumed grapefruit (grapefruit) fruits or products containing grapefruit (grapefruit) ingredients within 72 hours before the use of the study drug; 13. Screening patients who donated or lost more than 400 mL blood within the previous 3 months; 14. Participated in other clinical trials within 3 months prior to the trial; 15. Have a history of drug abuse or be positive for drug abuse screening (urine test); 16. Pregnant women, lactating women or women with positive pregnancy test before study administration; 17. Difficulty in venous blood collection; 18. Those who received the vaccine within 4 weeks before medication; 19. The researchers considered it unsuitable for participants to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-8;Tmax;T1/2;Vd/F; | — |
Countries
China
Contacts
Public ContactQin Yu
West China Second Hospital of Sichuan University
Outcome results
None listed