Pharmacokinetics and PharmacodynamicsNCT07600944
Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
A study testing Insulin Aspart Injection（UBLIN®） and Insulin Aspart Injection（NovoRapid®） 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® (test product) and NovoRapid® (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 Injection（UBLIN®） and Insulin Aspart Injection（NovoRapid®）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 3 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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).
- 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.
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 epilepsy;
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital)
Xingtai, Hebei, 054000
About this study
Official title: 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
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).
- Conditions
- Pharmacokinetics and Pharmacodynamics
- Being tested
- Insulin Aspart Injection（UBLIN®）, Insulin Aspart Injection（NovoRapid®）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Aspart Injection（UBLIN®）Drug
The dosage per cycle is 0.2 U/kg
Insulin Aspart Injection（NovoRapid®）Drug
The dosage per cycle is 0.2 U/kg
| Study group | Role | What they receive |
|---|---|---|
| UBLIN® | Experimental | Single subcutaneous administration of UBLIN® in dose 0.2 U/kg Receives: Drug: Insulin Aspart Injection（UBLIN®） |
| NovoRapid® | Active comparator | Single subcutaneous administration of NovoRapid® in dose 0.2 U/kg Receives: Drug: Insulin Aspart Injection（NovoRapid®） |
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 the Time of Last Measurable Concentration, AUC0-t
Measured: 0 to 10 hours
Peak Plasma Concentration of Insulin Aspart, Cmax
Measured: 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
Measured: 0 to 10 hours
Maximum Glucose Infusion Rate, GIRmax
Measured: 0 to 10 hours
Secondary outcomes (9)
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 2 Hours Post-Dose, AUC0-2h
Measured: 0 to 2 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
Measured: 2 to 10 hours
Time to Reach Peak Plasma Concentration of Insulin Aspart, Tmax
Measured: 0 to 10 hours
Elimination Rate Constant, λz
Measured: 0 to 10 hours
Half-Life of Insulin Aspart, t1/2
Measured: 0 to 10 hours
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to 2 Hours Post-Dose , AUCGIR0-2h
Measured: 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
Measured: 2 to 10 hours
Time Until Maximum Glucose Infusion Rate Is Reached, TGIRmax
Measured: 0 to 10 hours
Time To Onset Of Action, Tonset
Measured: 0 to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start6 May 2026
- Primary completion13 Jun 2026
- Study completion3 Jul 2026
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600944
- Sponsor's protocol ID
- TUL-MDYDS(PK/PD)202602
- Status last verified
- Aug 2026
- First submitted
- 6 May 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07600944
- Acronym / sponsor ID
- TUL-MDYDS(PK/PD)202602
- Conditions
- Pharmacokinetics and Pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Zhuhai United Laboratories Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 13 Jun 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two-Treatment, Two-period, Two-sequence Crossover
| Arm | Type | Receives |
|---|---|---|
| UBLIN® | Experimental | Drug: Insulin Aspart Injection（UBLIN®）Single subcutaneous administration of UBLIN® in dose 0.2 U/kg |
| NovoRapid® | Active comparator | Drug: Insulin Aspart Injection（NovoRapid®）Single subcutaneous administration of NovoRapid® in dose 0.2 U/kg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Aspart Injection（UBLIN®）The dosage per cycle is 0.2 U/kg | Drug | UBLIN® |
| Insulin Aspart Injection（NovoRapid®）The dosage per cycle is 0.2 U/kg | Drug | NovoRapid® |
Primary outcome
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t
Time frame: 0 to 10 hours
Peak Plasma Concentration of Insulin Aspart, Cmax
Time frame: 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
Time frame: 0 to 10 hours
Maximum Glucose Infusion Rate, GIRmax
Time frame: 0 to 10 hours
9 secondary outcomes
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to 2 Hours Post-Dose, AUC0-2h
Time frame: 0 to 2 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
Time frame: 2 to 10 hours
Time to Reach Peak Plasma Concentration of Insulin Aspart, Tmax
Time frame: 0 to 10 hours
Elimination Rate Constant, λz
Time frame: 0 to 10 hours
Half-Life of Insulin Aspart, t1/2
Time frame: 0 to 10 hours
Area Under The Curve (AUC) of Glucose Infusion Rate(GIR) From Time 0 to 2 Hours Post-Dose , AUCGIR0-2h
Time frame: 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
Time frame: 2 to 10 hours
Time Until Maximum Glucose Infusion Rate Is Reached, TGIRmax
Time frame: 0 to 10 hours
Time To Onset Of Action, Tonset
Time frame: 0 to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Aspart Injection（UBLIN®） and Insulin Aspart Injection（NovoRapid®） in people with Pharmacokinetics and Pharmacodynamics, run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t (time frame: 0 to 10 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.