Actively Recruiting
Comparison of the Pharmacokinetics and Pharmacodynamics Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Randomized, Double-Blinded, Crossover Study
Led by Zhuhai United Laboratories Co., Ltd. · Updated on 2026-05-22
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, pharmacodynamics, and safety of two insulin aspart injections, UBLIN4 and NovoRapid4, in healthy male volunteers. This study aims to compare these two products after a single dose to understand their behavior in the body. The trial is conducted as a randomized, double-blinded crossover study involving 44 healthy men stratified by race to assess biosimilarity between the test and reference drugs. Participants will receive a single subcutaneous dose of either UBLIN4 or NovoRapid4 at 0.2 units per kilogram during two study periods separated by 7 days. Each participant receives both treatments in different sequences to compare their effects accurately. The study uses a triple-blind design to prevent bias and closely monitors responses to these insulin injections. During the study, participants will undergo blood sampling to measure insulin aspart plasma concentration and glucose infusion rates over 10 hours after dosing. Researchers will evaluate key outcomes like peak plasma concentration, area under the curve (AUC) for insulin and glucose infusion rate, time to maximum concentration, and other pharmacodynamic parameters. Safety assessments and vital signs monitoring will also be conducted, with total participation lasting through the two dosing periods and associated follow-up.
CONDITIONS
Brief Title
Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male participants aged 18 to 55 years (inclusive)
- Male body weight at least 50.0 kg
- Body mass index between 19.0 and 28.0 kg/m2 (inclusive)
- Normal vital signs or abnormalities without clinical significance (systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse 60-100 beats/min, body temperature 36.06C to 37.06C)
- Normal glucose tolerance and insulin secretion function as determined by tests
- Ability to understand and voluntarily consent to the trial, communicate well, and comply with study requirements
You will not qualify if you...
- History of allergies to drugs, food, pollen, or insulin
- History of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- Clinically significant disorders affecting nervous, cardiovascular, blood, immune, renal, liver, gastrointestinal, respiratory, metabolic, or skeletal systems
- History of hypoglycemia, hypokalemia, orthostatic hypotension, syncope, blackout, diabetes, or family history of diabetes
- Severe vomiting or diarrhea within 7 days before the trial
- Surgery within 3 months prior or planned during the study affecting drug processing
- History of asthma or epilepsy
- Participation in other investigational trials within 6 months
- Use of medications affecting liver enzymes or insulin effect within 28 days
- Use of any drugs, health products, or vaccinations within 14 days before the trial
- Clinically significant abnormalities in physical examination, lab tests, or ECG within 14 days
- Positive tests for specific autoantibodies or infectious diseases
- Positive breath alcohol or drug abuse tests
- Use of illicit drugs within 1 year
- Excess alcohol consumption or inability to abstain during the trial
- Smoking more than 5 cigarettes daily or inability to stop tobacco use during the trial
- Excessive caffeine or intake of certain foods/beverages affecting drug metabolism
- Recent blood loss, donation, transfusion, or plans to donate blood during or after the trial
- Pregnancy or sperm donation plans without effective contraception
- Inability to eat normally or comply with diet requirements
- Engagement in high-risk work or activities
- Poor tolerance to blood draws or history of needle-induced syncope
- Poor compliance or other factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 hours per treatment session with crossover timing not specified
Participants receive single subcutaneous doses of either UBLIN® or NovoRapid® insulin aspart in a randomized, crossover design to compare pharmacokinetics and pharmacodynamics.
2 treatment visits (in-person) for each insulin administration
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Xingtai Medical College (Xingtai Cancer Hospital)
Xingtai, Hebei, China, 054000
Actively Recruiting
Research Team
Q
Qingtong Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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