diabetes
Conditions
Interventions
T-R group:TR
R-T group:RT
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects aged 18 to 45 (including 18 and 45 years old) at the time of informed consent; 2. Body mass index (BMI): 19.0-26.0 kg/m2 (including 19.0 kg/m2 and 26.0 kg/m2), and the body weight is between 50.0-80.0kg (including 50.0kg and 80.0kg); 3. Fasting blood glucose is normal and > 3.9 mmol/L; 4. No history of important organ diseases, physical examination, vital signs, laboratory and related examinations are normal or abnormal and have no clinical significance, and the clinical research doctor judges that they are qualified; 5. Subjects can understand the purpose and risks of the research and are willing to participate in the research and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of clinically significant drug allergies or atopic allergic diseases (asthma, urticaria, eczema dermatitis) or known allergies to test drugs or drugs similar to test drugs; 2. Suffering from dyspepsia, esophageal reflux, stomach bleeding or peptic ulcer disease in the current or recent 6 months, heartburn often occurs more than once (weekly), or any surgical operation that may affect drug absorption (such as Cholecystectomy); 3. Have a medical history or family history of medullary thyroid cancer (MTC) (grandparents, parents and siblings), or genetic diseases are likely to induce medullary thyroid cancer; 4. Those who have a history and clinical manifestations of acute or chronic pancreatitis, or the result of serum amylase concentration exceeds the upper limit of normal; 5. Those who have dermatitis or skin abnormalities at or around the administration site; 6. Those who have participated in any other clinical trials within 3 months before the study drug administration; 7. Those who have a history of major surgery within 3 months before drug administration or plan to undergo surgery within 14 days after drug administration; 8. Those with a history of blood loss or blood donation within 3 months before the administration of the study drug, and the loss or blood donation exceeds 300mL; 9. Vigorous exercise or other factors affecting drug absorption, distribution, metabolism, and excretion within 48 hours before administration; 10. Those who have received any prescription drugs, over-the-counter drugs, Chinese herbal medicines and vitamins within 2 weeks before the study drug administration; 11. Those who smoked more than 5 cigarettes or the same amount of tobacco per day during the 3 months before the study drug administration, or who could not quit smoking during the trial period; 12. People who have consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 200 mL) for a long time in the past; 13. Have a history of regular drinking in the 28 days before screening and drink more than 14 glasses per week (1 glass = 5 ounces (150 mL) wine = 12 ounces (360 mL) beer = 1.5 ounces (45 mL) of spirits), or alcohol at check-in Those whose breath test is positive (>0.0mg/100ml); 14. Those who have a history of drug abuse or who abuse drugs or have a positive urine screening test during check-in; 15. Human immunodeficiency virus antibody (HIV antibody), serum Treponema pallidum antibody (AntiTP), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (anti HCV) test results are abnormal and clinically significant By; 16. Subjects who refuse to use effective contraceptive measures (correct use of condoms) from the first medication to 6 months after the completion of the study; 17. Those who have special requirements for diet and cannot accept a unified diet; 18. Those who have difficulty in venous blood collection, or have a history of fainting needles or fainting blood; 19. The investigator believes that it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;ADA/Nab antibody detection; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed