No, healthy adult male subjects
Conditions
Interventions
first group:phase I: insulin asparagus injection
phase II: Novoxel
Second group:phase I: Novoxel
phase II: insulin asparagus injection
Sponsors
Department of Endocrinology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in the experiment and sign the informed consent; (2) Healthy male subjects aged 18 to 45 years (including 18 and 45 years); (3) No significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities was found by any researcher; no abnormalities or abnormalities were found in physical examination, electrocardiogram and laboratory examination (based on the judgement of clinicians). (4) BMI was 19.0-24.0 kg/m2 (including 19.0 and 24.0 kg/m2); (5) Normal glucose tolerance (fasting blood sugar < 6.1 mmol/L, and blood sugar < 7.8 mmol/L 2 hours after 75 grams of oral glucose) and normal islet secretion (judged by the results of insulin release test); (6) No family history of diabetes and obesity; Ability to communicate well with researchers and complete research in accordance with research requirements.
Exclusion criteria
Exclusion criteria: Anyone who occurs in one of the following circumstances shall not be included in this trial: (1) The positive results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody and syphilis test; (2) Those who are clearly allergic to insulin asparagus or its preparations; those who have allergies to drugs (including salicylic acid), allergic diseases or allergic constitutions; those who are allergic to any food or have special dietary requirements and cannot follow a unified diet; (3) Those who have used any prescription medicine, Chinese herbal medicine and/or over-the-counter drugs (except those who occasionally or restrictively used paracetamol) or health products (except routine vitamin supplements) within 4 weeks before administration; (4) Subjects who donated blood or plasma within one month before screening, or who donated more than 400 mL of blood within three months; (5) Those who smoke seriously (25 or more cigarettes a day); (6) Alcoholics (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or those with positive results of alcohol breathing tests; (7) Those with a history of drug abuse or positive urine test for contraband drugs; (8) Those who participated in any clinical trial within three months before the trial, or who planned to participate in other clinical trials during the trial or within one month after the end of the trial; (9) Those who cannot take contraceptive measures during the trial; Researchers do not consider it appropriate to participate in other situations of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK indicators: insulin aspartate and C-peptide levels;PD Indicators: GIR will be used as an index for evaluating PD; | — |
Countries
China
Contacts
Public ContactYuye Rong
Outcome results
None listed