Pharmacokinetics and PharmacodynamicsNCT07875803
Comparison of the Pharmacokinetic (PK) and Pharmacodynamic (PD) Biosimilarity of Insulin Aspart 30 Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
A study testing Insulin Aspart 30 Injection (UBLIN 30®)) and Insulin Aspart 30 Injection ( NovoMix®30) in people with Pharmacokinetics and Pharmacodynamics, run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.
Trial summary
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN 30® (test product) and NovoMix®30 (reference product) in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics and Pharmacodynamics
- What is being tested?
- Insulin Aspart 30 Injection (UBLIN 30®)) and Insulin Aspart 30 Injection ( NovoMix®30)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 28 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- 3.90 mmol/L < fasting plasma glucose (FPG) < 6.10 mmol/L, 2-hour postprandial blood glucose after oral glucose tolerance test (OGTT) < 7.80 mmol/L, glycated 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.
Who cannot join
- 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 seizure disorder;
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- Has participated in any other investigational product or device clinical trial and received investigational product within 3 months prior to the study (except for screening-only, non-enrolled cases or enrolled cases with no study-treatment exposure);
- 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 supplements, herbal 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 use 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 and/or poor venous access;
- Has 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital)
Xingtai, Hebei, 054000
Fengxue Guo, 0319-2279911, fxguo2023@163.com
About this study
Official title: Comparison of the Pharmacokinetic (PK) and Pharmacodynamic (PD) Biosimilarity of Insulin Aspart 30 Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center, Randomized, Double-blinded, Two-Treatment, Two-period, Two-sequence Crossover Study
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN 30® (test product) and NovoMix®30 (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 52 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).
- Conditions
- Pharmacokinetics and Pharmacodynamics
- Being tested
- Insulin Aspart 30 Injection (UBLIN 30®)), Insulin Aspart 30 Injection ( NovoMix®30)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Aspart 30 Injection (UBLIN 30®))Drug
The dosage per cycle is 0.3 U/kg
Insulin Aspart 30 Injection ( NovoMix®30)Drug
The dosage per cycle is 0.3 U/kg
| Study group | Role | What they receive |
|---|---|---|
| UBLIN 30® | Experimental | Single subcutaneous administration of UBLIN 30® in dose 0.3 U/kg Receives: Drug: Insulin Aspart 30 Injection (UBLIN 30®)) |
| NovoMix®30 | Active comparator | Single subcutaneous administration of NovoMix®30 in dose 0.3 U/kg Receives: Drug: Insulin Aspart 30 Injection ( NovoMix®30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC）of Insulin Aspart Plasma Concentration From Time 0 to τ (a dosing interval of 24 h)，AUC0-τ
Measured: 0 to 36 hours
Peak Plasma Concentration of Insulin Aspart, Cmax
Measured: 0 to 36 hours
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to τ (a dosing interval of 24 h)，AUCGIR,0-τ
Measured: 0 to 24 hours
Maximum Glucose Infusion Rate, GIRmax
Measured: 0 to 24 hours
Secondary outcomes (13)
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 4 Hours Post--Dose, AUC0-4h
Measured: 0 to 4 hours
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From 4 Hours Post-dose to the Time of Last Measurable Concentration, AUC4-t
Measured: 4 to 36 hours
Area Under the Curve (AUC} of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t
Measured: 0 to 36 hours
Area Under the Curve (AUC）of Insulin Aspart Plasma Concentration From Time 0 to the Time of infinity, AUC0-∞
Measured: 0 to 36 hours
Time to Reach Peak Plasma Concentration of Insulin Aspart,Tmax
Measured: 0 to 36 hours
Elimination Rate Constant,入z
Measured: 0 to 36 hours
HaIf-Life of InsuIin Aspart, t1/2
Measured: 0 to 36 hours
Apparent Clearance, CL/F
Measured: 0 to 36 hours
Apparent Volume of Distribution, Vz/F
Measured: 0 to 36 hours
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to 4 Hours Post-Dose , AUCGIR,0-4h
Measured: 0 to 4 hours
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 4 to 24 Hours Post-Dose , AUCGIR,4-24h
Measured: 4 to 24 hours
Time Until Maximum Glucose Infusion Rate Is Reached, TGIRmax
Measured: 0 to 24 hours
Time To Onset Of Action, Tonset
Measured: 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics and PharmacodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-Treatment, Two-period, Two-sequence Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengxue Guo, Principal investigator, The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875803
- Sponsor's protocol ID
- TUL-MDYDS30（PK/PD）202612
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided