The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN® (test product) and NovoRapid® (reference product) in healthy male participants. The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 7 days between dosing. A total of 44 participants will be enrolled in this trial and randomized in a 1:1 ratio into two groups (A/B), stratified by race (Asian, non-Asian).
Healthy male participants aged 18 to 55 years (inclusive).
Body weight: Male ≥ 50.0 kg, body mass index [BMI = weight (kg)/height2 (m2)] between 19.0 and 28.0 kg/m2 (inclusive).
Individuals with normal vital signs or abnormalities without clinical significance (normal reference range: 90 mmHg ≤ systolic blood pressure (supine) < 140 mmHg, 60 mmHg ≤ diastolic blood pressure (supine) < 90 mmHg, 60 beats/min ≤ pulse < 100 beats/min, 36.0°C ≤ body temperature ≤ 37.0°C).
Normal glucose tolerance (3.90 mmol/L < fasting plasma glucose (FPG) < 6.10 mmol/L, and 2-hour postprandial blood glucose after oral glucose tolerance test (OGTT) < 7.80 mmol/L), glycosylated haemoglobin value between 4.0% and 6.0% (inclusive), and normal insulin secretion function (as determined by the investigator based on insulin release test results).
History of specific allergies (e.g., asthma, urticaria, eczema), or those allergic to any drug, food, or pollen, or known to be allergic to insulin;
History of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
Has clinically significant abnormal conditions requiring exclusion, including but not limited to system disorders of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, especially a history of hypoglycemia, hypokalemia, orthostatic hypotension, syncope or blackout, diabetes mellitus, or a family history of diabetes mellitus (first-degree relatives);
Has a history of severe vomiting, diarrhoea within 7 days prior to the trial, or has any other disease or physiological condition that may interfere with the trial results;
Crossover
Insulin Aspart Injection（UBLIN®）
DrugThe dosage per cycle is 0.2 U/kg
Insulin Aspart Injection（NovoRapid®）
DrugThe dosage per cycle is 0.2 U/kg
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t
Peak Plasma Concentration of Insulin Aspart, Cmax
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 To End Of Clamp At Time T, AUCGIR0-t
Maximum Glucose Infusion Rate, GIRmax
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 2 Hours Post-Dose, AUC0-2h
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From 2 Hours Post-dose to the Time of Last Measurable Concentration, AUC2-t
Time to Reach Peak Plasma Concentration of Insulin Aspart, Tmax
Elimination Rate Constant, λz
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