Evaluation of Pharmacokinetics and Safety of the Biosimilar (B01711) and Insulin Degludec/Insulin Aspart (IDegAsp, Ryzodeg) in Healthy Chinese Adults in a Randomized, Open-Label, Single-Dose, Crossover, Phase I Study

What Was Tested

The paper reports a study of Insulin Aspart, published as a randomized controlled trial.

B01711 is a biosimilar of insulin degludec/insulin aspart (IDegAsp 70/30).

Who Took Part

According to the abstract, 32 participants were involved.

By PubMed's age tags, the people studied were young adults and adults, both men and women.

The study was conducted between April and August 2022, this study included 32 participants (22 males and 10 females) who received subcutaneous injections of both B01711 and Ryzodeg, with a ≥14-day washout period between treatments.

All participants completed the study without any dropouts.

How the Study Was Run

In design terms this was a randomized, open-label and crossover study.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Blood samples were collected at pre-defined intervals for PK analysis.

What Was Measured

PubMed files the paper under topics including Area Under Curve, Drug Combinations, Healthy Volunteers, Hypoglycemic Agents, Insulin Aspart, Insulin, Long-Acting and East Asian People.

Author keywords: B01711, IDegAsp, Ryzodeg, healthy subjects and phase I study.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Insulin Aspart in 32 participants.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2025 (Drug design, development and therapy), a journal based in New Zealand.

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