Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart I… (NCT07600944) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
China44 participantsStarted 2026-05-06
Plain-language summary
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).
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t
Timeframe: 0 to 10 hours
2
Peak Plasma Concentration of Insulin Aspart, Cmax
Timeframe: 0 to 10 hours
3
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 To End Of Clamp At Time T, AUCGIR0-t
. 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);