Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart.

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).

It had two arms (groups): UBLIN® (experimental) and NovoRapid® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 44 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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).

The full record lists 5 inclusion and 25 exclusion criteria; among the exclusions: 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 a history of asthma or epilepsy;.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2026-05-06 with completion listed for 2026-06-13.

It ran at 1 site in China.

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main 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). 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).

It also tracked 9 secondary outcomes, for example Time to Reach Peak Plasma Concentration of Insulin Aspart, Tmax, Elimination Rate Constant, λz, Half-Life of Insulin Aspart, t1/2, Time Until Maximum Glucose Infusion Rate Is Reached, TGIRmax and Time To Onset Of Action, Tonset.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 44 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.