Comparison of the Pharmacokinetic (PK) and Pharmacodynamic (PD) Biosimilarity of Insulin Aspart 30 Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers

What Was Tested

The trial (not phased) is built around Insulin Aspart.

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).

It had two arms (groups): UBLIN 30® (experimental) and NovoMix®30 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 52 planned participants were the target.

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 26 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 seizure disorder;.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2026-10-20 with completion listed for 2027-02-28.

It ran at 1 site in China.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Peak Plasma Concentration of Insulin Aspart, Cmax (time frame: 0 to 36 hours). Maximum Glucose Infusion Rate, GIRmax (time frame: 0 to 24 hours).

It also tracked 13 secondary outcomes, for example Area Under the Curve (AUC} of Insulin Aspart Plasma Concentration From Time 0 to the Time of Last Measurable Concentration, AUC0-t, Area Under the Curve (AUC）of Insulin Aspart Plasma Concentration From Time 0 to the Time of infinity, AUC0-∞, Time to Reach Peak Plasma Concentration of Insulin Aspart,Tmax, Elimination Rate Constant,入z, HaIf-Life of InsuIin Aspart, t1/2 and Apparent Clearance, CL/F.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 52 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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