Diabetes
Conditions
Interventions
Group A:The experimental preparation insulin aspartic injection was injected in the first cycle, and the reference preparation insulin aspartic injection was injected in the second cycle
Group B:Injected with reference preparation insulin aspartic injection in the first cycle and test preparation insulin aspartic injection in the second cycle
Sponsors
The Second Affiliated Hosptial of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Participate voluntarily in the trial and sign the informed consent; 2. Healthy adult male subjects aged 18 to 45 years (including 18 and 45 years old); 3. The weight of the subject is >= 50.0 kg, and the body mass index is 19.0 ~ 26.0 kg / m2 (Including 19.0 and 24.0 kg / m2); 4. Normal glucose tolerance (fasting blood glucose < 6.1 mmol / L and 2 hours after oral administration of 75 grams of glucose blood glucose < 7.8mmol / L), islet secretion function is normal (the investigator passed the insulin release test results Fruit judgment); 5. Be able to communicate well with researchers and complete research in accordance with research regulations.
Exclusion criteria
Exclusion criteria: 1. Abnormal results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, and syphilis are clinically significant; 2. Patients who are clearly allergic to insulin aspartic or its preparation ingredients; People with drug (including salicylic acid) or food allergies, or allergic conditions; 3. Patients who have special requirements on diet or cannot follow a uniform diet; 4. Patients who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products (except regular vitamin supplements) within 4 weeks before administration; 5. Patients who have a history of current or previous diseases, such as heart, liver, kidney, digestive tract, nervous system, respiratory system, mental and metabolic abnormalities, which the researcher considers to be meaningful; 6. Abnormal results of physical examination, vital signs, electrocardiogram, chest CT and laboratory examination are clinically significant (subject to the judgment of clinicians); 7. Patients who donated blood within 1 month prior to screening, or donated or lost more than 400 mL of blood within 3 months, or plan to donate blood or blood components during the study or within 3 months after the study; 8. Patients who smoke heavily (5 or more cigarettes per day) or who are not allowed to smoke during the entire study period after inclusion; 9. Alcoholics (drinking more than 14 units of alcohol per week: 1 unit ˜ 365mL beer, or 45mL 40% spirits, or 150mL wine) or alcohol breath test results greater than 0.0mg/100ml; 10. People who drank too much tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day, or did not agree to abstain from grapefruit juice or any food or beverage containing alcohol and xanthine (including chocolate, tea, coffee, cola, etc.) for 48 hours before administration and throughout the study period; 11. Patients with a history of drug abuse or positive urine test for illicit drugs; 12. Patients who have difficulty in venous blood acquisition, or cannot tolerate venipuncture, or have a history of needle sickness and blood sickness; 13. Patients in any clinical trial within 3 months prior to the trial or who plan to participate in another clinical trial during the trial or within 1 month after the trial; 14. Other circumstances that the researcher considers inappropriate for participation in the study; 15. Family history of diabetes or obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration;0-10h Area Under The Curv; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hosptial of Xingtai Medical College
Outcome results
None listed