diabetes
Conditions
Interventions
Sponsors
The Second Affiliated Hosptial of Xingtai Medical College
Eligibility
Sex/Gender
All
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 26.0 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) Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, and syphilis test results are abnormal and have clinical significance; (2) Have clearly allergic to insulin aspart or its ingredients ;have drugs (including salicylic acid) or food allergies;have allergies; (3) Those who have special dietary requirements; cannot follow a unified diet; (4) Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products (except regular vitamin supplements) within 4 weeks before administration; (5) Researchers believe that meaningful heart, liver, kidney, digestive tract, nervous system, respiratory system those who have or have a history of illnesses such as systemic, mental abnormalities and metabolic abnormalities; (6) Physical examination, vital signs, electrocardiogram, chest CT and laboratory examinations, etc., with abnormal clinical significance (subject to the judgment of the clinician); (7) Subjects who donated blood within one month before screening, or who donated blood or lost more than 400 mL within 3 months, or plan to study during or at the end of the study; (8) Evere smoking (5 or more cigarettes per day), or those who cannot accept no-smoking after the enrollment to the entire trial (9) Alcoholics (drinking more than 14 units of alcohol per week: 1 unit ˜ 365mL of beer, or alcohol content of 40% spirits 45mL, or wine 150mL) or alcohol breath test results greater than 0.0mg / 100ml; (10) Those who consume excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or do not agree to ban the use of grapefruit juice or any alcohol and xanthine 48 hours before the administration and throughout the study Including chocolate, tea, coffee, cola, etc.) food and drink; (11) Those with a history of drug abuse or a positive urine test for contraband drugs; (12) Those who have difficulty in venous blood, or cannot tolerate venipuncture, or have a history of halo acupuncture; (13) Those who participated in any clinical trial within 3 months before the trial, or plan to participate in other clinical trials within the trial period or within 1 month after the end of the trial; (14) The investigator considers it inappropriate to participate in other situations of this study. (15) With family history of diabetes or obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin aspart;C peptide;Cmax;AUC0-10h;GIRmax;GIR-AUC0-10h; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-8;Tmax;t1/2z;tGIRmax; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hosptial of Xingtai Medical College
Outcome results
None listed