a study evaluating the bioavailability of oral insulin (n11005)

Conditions: PK, PD, and Safety

Summary: the objective of this study was to preliminarily verify whether the oral insulin n11005 is a prandial insulin by assessing the pk, pd, and safety profiles of n11005.


Eligibility criteria:
inclusion criteria: * 1) volunteer to participate in the trial and sign an informed consent form; 2) 18-45 years old (including 18 and 45 years old) healthy male subjects (without heart, liver, kidney, digestive tract, neurological diseases, and metabolic abnormalities in the 4 weeks before screening; no abnormal clinically significant vital signs results, physical examination results, laboratory examination results and electrocardiogram examination results judged by the investigator at the time of screening); 3) bmi (body mass index): between 19-24 kg/m2, including 19 and 24 kg/m2; 4) normal glucose tolerance (fasting plasma glucose \[fpg\] \<6.1 mmol/l, and oral glucose tolerance test \[ogtt\] 2-hour postprandial blood glucose \<7.8 mmol/l); 5) no family history of diabetes, obesity, etc.; 6) insulin secretion function is normal (confirmed by insulin release test (irt) judged by the investigator); 7) there is no planned parenthood during the study period, and it is agreed to use reliable contraceptive measures during the study period until 4 weeks after the last administration of the study drug; 8) be able to communicate well with researchers and complete research in accordance with research regulations. exclusion criteria: * 1). those who have serious systemic diseases, infectious diseases or mental disorders; 2). the results of human immunodeficiency virus (hiv) antibody, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibody, syphilis test are positive; 3). those who have used any prescription drugs, chinese herbal medicines and/or over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol) and health products (except routine vitamin supplements) within 2 weeks before screening; 4). those who donated more than 400 ml of blood within 3 months before screening; 5). severe smokers (25 or more cigarettes per 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 who have a positive alcohol breath test result; 7). those who have a history of drug abuse or have a positive urine test for illegal drugs; 8). those who are known or suspected to be allergic to insulin and/or its excipients; 9). those who have participated in other clinical trials within 3 months before screening, or plan to participate in other clinical trials during the trial period or within 1 month after the end of the trial; 10). those who have any food allergies or have special dietary requirements and cannot follow a unified diet; 11). those who have undergone gastrointestinal surgery before screening, or have a history of gastric obstruction or impaired gastrointestinal motility; 12). those who are using gastric mucosal protective agents during screening; 13). those who are deemed unsuitable to participate in this trial after the researcher's evaluation;