Pharmacokinetics and PharmacodynamicsPhase 1NCT07608692

Comparative Clinical Trial of Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

A Phase 1 study testing Human Insulin Injection（USLIN®R） and Human Insulin Injection（NOVOLIN®R） in people with Pharmacokinetics and Pharmacodynamics, run by Zhuhai United Laboratories Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: Human Insulin Injection（USLIN®R） and Human Insulin Injection（NOVOLIN®R）
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 4 Aug 2025to 13 Jan 2026
Phase: Phase 1
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

Age: 18 to 55 years old (inclusive of 18 and 55 years).
Gender: Male.
Body Weight: Not less than 55.0 kg for men, with a body mass index [BMI = weight (kg) / height² (m²)] between 18.0 and 29.0 kg/m² (inclusive of boundary values).
Vital Signs: Systolic blood pressure ≥90 mmHg and <140 mmHg, diastolic blood pressure ≥60 mmHg and <90 mmHg, pulse rate ≥60 beats/min and ≤100 beats/min, body temperature (forehead) between 36.0°C and 37.3°C, with final judgment by the investigator.
Glucose Tolerance: Normal glucose tolerance (fasting plasma glucose (FPG) <6.10 mmol/L and >3.50 mmol/L, and 2-hour postprandial blood glucose in oral glucose tolerance test (OGTT) <140 mg/dL (7.78 mmol/L)), glycated hemoglobin value <6.3% and >4.5%.

Who cannot join

Those who have participated in a clinical trial of another drug/device and used the investigational drug/device within 6 months.
Those with clinically significant abnormal conditions requiring exclusion, including but not limited to neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal system disorders, particularly those with a history of hypoglycemia, hypokalemia, postural hypotension, syncope or blackout, diabetes mellitus, or a family history (first-degree relatives) of diabetes mellitus.
Those with a history of severe vomiting, diarrhea, or any other disease or condition that could interfere with trial results within 7 days prior to the trial.
Those with a history of specific allergies (e.g., asthma, urticaria, eczema) or allergies to any medications, foods, or pollen, or known allergies to insulin.
Those with positive anti-insulin antibodies.
Those who have lost or donated more than 400 mL of blood, received blood transfusions, or used blood products within 3 months prior to the trial, or who plan to donate blood during the trial.

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Subjects with plans for childbearing or sperm donation from 2 weeks prior to the trial to 6 months after the last dose, and who are unwilling or unable to use effective contraception.
Those with clinically significant abnormalities in general physical examination, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, etc.) within 7 days prior to the trial, or electrocardiogram results deemed clinically significant by the clinician within 14 days prior to the trial.
Those with one or more clinically significant positive results for hepatitis B, hepatitis C, HIV, or syphilis tests.
Those who have undergone surgery within 3 months prior to the trial, plan to undergo surgery during the study, or have had surgery that affects drug absorption, distribution, metabolism, or excretion.
Those who consumed more than 14 units of alcohol per week within 3 months prior to the trial (1 unit = 17.7 mL ethanol, i.e., 354 mL of 5% alcohol beer, 44 mL of 40% alcohol liquor, or 147 mL of 12% alcohol wine), or those unable to abstain from alcohol during the trial.
Those who smoked an average of more than 5 cigarettes per day within 3 months prior to the trial, or those unable to stop using any tobacco-based or nicotine products (e.g., nicotine patches, chewing gums) during the trial.
Those who consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months prior to the trial.
Those who consumed any food or beverage rich in caffeine/xanthine or other special ingredients (e.g., strong tea, coffee, chocolate, cola, animal offal, grapefruit, grapefruit juice, dragon fruit, mango) from screening to 2 days before admission, which, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion, or those unable to stop consuming such foods or beverages by the end of drug administration.
Those who used any drugs that alter liver enzyme activity within 28 days prior to the trial (common liver enzyme inducers: barbiturates (phenobarbital being the most common), carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, sulfonamides).
Those who used any drugs affecting insulin's glucose-lowering effects within 28 days prior to the trial (e.g., corticosteroids, danazol, diazoxide, diuretics, epinephrine, salbutamol, terbutaline, glucagon, growth hormone, thyroid hormone, beta-blockers).
Those unable to eat, with swallowing difficulties, special dietary requirements, or unable to follow a standardized diet.
Those who used any prescription drugs, over-the-counter drugs, nutraceuticals, herbal products, or vaccines within 14 days prior to the trial.
Those engaged in hazardous mechanical operations, such as working at heights or driving motor vehicles.
Those unable to tolerate venipuncture or with a history of hemophobia or needle phobia.
Those with a history of asthma or seizures.
Those with a history of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
；Those who used any illicit drugs within one year prior to the trial.
Those with a positive alcohol breath test or positive drug abuse screening.
Subjects deemed by the investigator to have poor treatment compliance or any factors making participation in this trial inappropriate.

Trial locations and contacts

1 site in 1 country.

China1 site

28 Baofeng Road, Qiaokou District
Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

A study of Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection,in Wuhan Pulmonary Hospital (Wuhan Tuberculosis Prevention and Control Institute).To compare the pharmacokinetic and pharmacodynamics properties of a single subcutaneous dose of the human insulin injection (USLIN®R, Zhuhai United Laboratories (Zhongshan) Co., Ltd.) with the reference product (Novolin®R, Novo Nordisk Inc.) in healthy male subjects,and to evaluate the safety, tolerability, and immunogenicity of the test formulation versus the reference formulation in healthy male subjects.This single-center, randomized, double-blind, two-formulation, single-dose, two-period crossover study will enroll 32 healthy male subjects randomized 1:1 into two sequence groups (A/B, group A is administered in the sequence of T-R, while group B is in R-T). To evaluate the pharmacokinetic and pharmacodynamic properties of the test preparation and the control preparation in healthy male subjects. Each subject will receive single doses of both test and reference formulations across two periods (with ≥14-day washout), following the predefined sequence allocation table. After completing period 2 pharmacokinetic blood sampling, subjects will administer assigned insulin TID for two consecutive days to assess test-reference immunogenicity differences.

Conditions: Pharmacokinetics and Pharmacodynamics
Being tested: Human Insulin Injection（USLIN®R）, Human Insulin Injection（NOVOLIN®R）

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Insulin Injection（USLIN®R）Drug
a single subcutaneous dose of 0.3 IU/kg
Human Insulin Injection（NOVOLIN®R）Drug
a single subcutaneous dose of 0.3 IU/kg

Study groups in NCT07608692
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Drug: Human Insulin Injection（USLIN®R）; Drug: Human Insulin Injection（NOVOLIN®R）
Group B	Active comparator	Not described Receives: Drug: Human Insulin Injection（USLIN®R）; Drug: Human Insulin Injection（NOVOLIN®R）

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary PK Parameters (Peak Plasma Concentration (Cmax）)
PK Parameters (Peak Plasma Concentration (Cmax）)
Measured: 0 to 12 hours
Primary PK Parameters (Area under the plasma concentration-time curve from time 0 to time τ(AUC0-τ))
Area under the plasma concentration-time curve from time 0 to time τ(AUC0-τ)
Measured: 0 to 12 hours
Primary PD Parameters (Area under the glucose infusion rate curve from time 0 to time τ(AUCGIR0-τ))
Area under the glucose infusion rate curve from time 0 to time τ(AUCGIR0-τ)
Measured: 0 to 12 hours
Primary PD Parameters (Maximum glucose infusion rate (GIRmax))
Maximum glucose infusion rate (GIRmax)
Measured: 0 to 12 hours

Secondary outcomes (8)

Secondary PK Parameters (Area under the plasma concentration-time curve from time 0 to time 2 hours(AUC0-2h))
Area under the plasma concentration-time curve from time 0 to time 2 hours(AUC0-2h)
Measured: 0 to 2 hours
Secondary PK Parameters (Area under the plasma concentration-time curve from time 0 extrapolated to infinity(AUC0-∞))
Area under the plasma concentration-time curve from time 0 extrapolated to infinity(AUC0-∞)
Measured: 0 to 12 hours
Secondary PK Parameters (Time to maximum (peak) plasma concentration(Tmax))
Time to maximum (peak) plasma concentration(Tmax)
Measured: 0 to 12 hours
Secondary PK Parameters (Terminal elimination rate constant(λz))
Terminal elimination rate constant(λz)
Measured: 0 to 12 hours
Secondary PK Parameters (Elimination half-life(t1/2))
Elimination half-life(t1/2)
Measured: 0 to 12 hours
Secondary PD Parameters (Area under the glucose infusion rate curve from time 0 to 2 hours(AUCGIR0-2h))
Area under the glucose infusion rate curve from time 0 to 2 hours(AUCGIR0-2h)
Measured: 0 to 2 hours
Secondary PD Parameters (Time to reach maximum glucose infusion rate(TGIRmax))
Time to reach maximum glucose infusion rate(TGIRmax)
Measured: 0 to 12 hours
Secondary PD Parameters (Time to onset of action,Tonset)
Time to onset of action,Tonset
Measured: 0 to 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202513 Jan 2026

First posted27 May 2026
Study start4 Aug 2025
Primary completion25 Nov 2025
Study completion13 Jan 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 1
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07608692
Sponsor's protocol ID: PD-INS-PK-PD355
Status last verified: May 2026
First submitted: 5 May 2026
Last updated: 1 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection
ClinicalTrials.gov ID: NCT07608692
Acronym / sponsor ID: PD-INS-PK-PD355
Conditions: Pharmacokinetics and Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Zhuhai United Laboratories Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Aug 2025 (actual)
Primary completion: 25 Nov 2025 (actual)
Study completion: 13 Jan 2026 (actual)
First posted: 27 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.

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: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial

Arm	Type	Receives
Group A	Experimental	Drug: Human Insulin Injection（USLIN®R）, Drug: Human Insulin Injection（NOVOLIN®R）
Group B	Active comparator	Drug: Human Insulin Injection（USLIN®R）, Drug: Human Insulin Injection（NOVOLIN®R）

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age: 18 to 55 years old (inclusive of 18 and 55 years).
Gender: Male.
Body Weight: Not less than 55.0 kg for men, with a body mass index [BMI = weight (kg) / height² (m²)] between 18.0 and 29.0 kg/m² (inclusive of boundary values).
Vital Signs: Systolic blood pressure ≥90 mmHg and <140 mmHg, diastolic blood pressure ≥60 mmHg and <90 mmHg, pulse rate ≥60 beats/min and ≤100 beats/min, body temperature (forehead) between 36.0°C and 37.3°C, with final judgment by the investigator.
Glucose Tolerance: Normal glucose tolerance (fasting plasma glucose (FPG) <6.10 mmol/L and >3.50 mmol/L, and 2-hour postprandial blood glucose in oral glucose tolerance test (OGTT) <140 mg/dL (7.78 mmol/L)), glycated hemoglobin value <6.3% and >4.5%.

Key exclusion criteria (25 listed)

Those who have participated in a clinical trial of another drug/device and used the investigational drug/device within 6 months.
Those with clinically significant abnormal conditions requiring exclusion, including but not limited to neurological, cardiovascular, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal system disorders, particularly those with a history of hypoglycemia, hypokalemia, postural hypotension, syncope or blackout, diabetes mellitus, or a family history (first-degree relatives) of diabetes mellitus.
Those with a history of severe vomiting, diarrhea, or any other disease or condition that could interfere with trial results within 7 days prior to the trial.
Those with a history of specific allergies (e.g., asthma, urticaria, eczema) or allergies to any medications, foods, or pollen, or known allergies to insulin.
Those with positive anti-insulin antibodies.

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
Human Insulin Injection（USLIN®R）a single subcutaneous dose of 0.3 IU/kg	Drug	Group A, Group B
Human Insulin Injection（NOVOLIN®R）a single subcutaneous dose of 0.3 IU/kg	Drug	Group A, Group B

Primary outcome

Primary PK Parameters (Peak Plasma Concentration (Cmax）)
Time frame: 0 to 12 hours
PK Parameters (Peak Plasma Concentration (Cmax）)
Primary PK Parameters (Area under the plasma concentration-time curve from time 0 to time τ(AUC0-τ))
Time frame: 0 to 12 hours
Area under the plasma concentration-time curve from time 0 to time τ(AUC0-τ)
Primary PD Parameters (Area under the glucose infusion rate curve from time 0 to time τ(AUCGIR0-τ))
Time frame: 0 to 12 hours
Area under the glucose infusion rate curve from time 0 to time τ(AUCGIR0-τ)
Primary PD Parameters (Maximum glucose infusion rate (GIRmax))
Time frame: 0 to 12 hours
Maximum glucose infusion rate (GIRmax)

8 secondary outcomes

Secondary PK Parameters (Area under the plasma concentration-time curve from time 0 to time 2 hours(AUC0-2h))
Time frame: 0 to 2 hours
Secondary PK Parameters (Area under the plasma concentration-time curve from time 0 extrapolated to infinity(AUC0-∞))
Time frame: 0 to 12 hours
Secondary PK Parameters (Time to maximum (peak) plasma concentration(Tmax))
Time frame: 0 to 12 hours
Secondary PK Parameters (Terminal elimination rate constant(λz))
Time frame: 0 to 12 hours
Secondary PK Parameters (Elimination half-life(t1/2))
Time frame: 0 to 12 hours
Secondary PD Parameters (Area under the glucose infusion rate curve from time 0 to 2 hours(AUCGIR0-2h))
Time frame: 0 to 2 hours
Secondary PD Parameters (Time to reach maximum glucose infusion rate(TGIRmax))
Time frame: 0 to 12 hours
Secondary PD Parameters (Time to onset of action,Tonset)
Time frame: 0 to 12 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 1 Jun 2026.

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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?

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 1 Jun 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Primary PK Parameters (Peak Plasma Concentration (Cmax）) (time frame: 0 to 12 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?

On the ClinicalTrials.gov record for NCT07608692.

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 1 Jun 2026.