NCT07600944已完成不适用
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center, Randomized, Double-blinded, Two-Treatment, Two-period, Two-sequence Crossover Study
Zhuhai United Laboratories Co., Ltd.1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年5月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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).
- •Has fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial before participation, voluntarily participates in this clinical trial, being able to communicate well with the investigator, complying with all study requirements, and has signed the written informed consent form.
排除标准
- •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;
- •Has undergone surgery within 3 months prior to the study, or plans to undergo surgery during the study period; or has undergone any surgery that may affect drug absorption, distribution, metabolism, or excretion;
- •Has a history of asthma or epilepsy;
- •Has participated in any other investigational product or device clinical trial and received investigational product within 6 months prior to the study;
- •Has taken any medications that alter liver enzyme activity within 28 days prior to the trial (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, sulfonamides);
- •Has taken any medications that affect the hypoglycemic effect of insulin within 28 days prior to the trial (e.g., corticosteroids, danazol, diazoxide, diuretics, epinephrine, albuterol, terbutaline, glucagon, growth hormone, thyroid hormones, beta-blockers, etc.);
- •Has used any prescription drugs, over-the-counter drugs, health products, traditional Chinese medicines, or received vaccinations within 14 days prior to the trial;
- •Has any clinically significant abnormality identified by the investigator in general physical examination, laboratory tests (including hematology, blood biochemistry, coagulation, urinalysis, etc.), or 12-lead ECG within 14 days prior to the study;
- •Has clinically significant abnormalities in glutamic acid decarboxylase autoantibodies (GAD), islet cell cytoplasmic autoantibodies (ICA), or insulin autoantibodies (IAA) results as judged by the investigator;
- •Has clinically significant abnormalities in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis-specific antibody tests;
- •Has a breath alcohol test result > 0.0 mg/100 mL or a positive drug abuse screening;
- •Has used any illicit drugs within one year prior to the trial;
- •Has consumed more than 14 units of alcohol per week within 3 months prior to the trial (1 unit = 17.7 mL of ethanol, i.e., 1 unit = 354 mL of beer with 5% alcohol, or 44 mL of liquor with 40% alcohol, or 147 mL of wine with 12% alcohol), or is unable to abstain from alcohol during the trial;
- •Has smoked more than 5 cigarettes per day on average within 3 months prior to the trial, or is unable to stop using any tobacco products or nicotine-containing products (e.g., nicotine patches, chewing gum, etc.) during the trial;
- •Has excessively consumed tea, coffee, and/or caffeine-rich beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to the trial;
- •Has consumed any food or beverages rich in caffeine/xanthine or other special ingredients (such as strong tea, coffee, chocolate, cola, animal offal, grapefruit, grapefruit juice, pitaya, mango, etc.) from screening to 3 days prior to dosing and the diet is judged by the investigator to potentially affect the absorption, distribution, metabolism, and excretion of the drug, or is unable to abstain from such foods or beverages during the trial;
- •Has had blood loss or donated more than 200 mL of blood, received a blood transfusion, or used blood products within 3 months prior to the trial, or plans to donate blood during the trial or within 6 months after the last dose;
- •Has a pregnancy or sperm donation plan from 2 weeks prior to study start until 6 months after the last dose of study drug, and is unwilling or fails to take effective contraception;
- •Is unable to eat normally or has swallowing difficulties, has special dietary requirements, or is unable to comply with the standardized dietary protocol for the trial;
- •Is engaged in high-altitude work, motor vehicle driving, or other mechanical operations with potential safety hazards;
- •Has poor tolerance to venipuncture, or a history of syncope induced by blood or needle exposure;
- •Has been deemed by the investigator to have poor compliance or has any other factors unsuitable for participation in this trial.
研究组 & 干预措施
UBLIN®
Experimental
Single subcutaneous administration of UBLIN® in dose 0.2 U/kg
干预措施: Insulin Aspart Injection（UBLIN®） (Drug)
NovoRapid®
Active Comparator
Single subcutaneous administration of NovoRapid® in dose 0.2 U/kg
干预措施: Insulin Aspart Injection（NovoRapid®） (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t
时间窗: 0 to 10 hours
Peak Plasma Concentration of Insulin Aspart, Cmax
时间窗: 0 to 10 hours
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 To End Of Clamp At Time T, AUCGIR0-t
时间窗: 0 to 10 hours
Maximum Glucose Infusion Rate, GIRmax
时间窗: 0 to 10 hours
次要结局
- Half-Life of Insulin Aspart, t1/2(0 to 10 hours)
- Time to Reach Peak Plasma Concentration of Insulin Aspart, Tmax(0 to 10 hours)
- Elimination Rate Constant, λz(0 to 10 hours)
- Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From 2 Hours Post-dose to the Time of Last Measurable Concentration, AUC2-t(2 to 10 hours)
- Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 2 Hours Post-Dose, AUC0-2h(0 to 2 hours)
- Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to 2 Hours Post-Dose , AUCGIR0-2h(0 to 2 hours)
- Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From 2 Hours Post-dose To End Of Clamp At Time T, AUCGIR2-t(2 to 10 hours)
- Time Until Maximum Glucose Infusion Rate Is Reached, TGIRmax(0 to 10 hours)
- Time To Onset Of Action, Tonset(0 to 10 hours)
研究者
研究点 (1)
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