Clinical Trial

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

Completed
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Summary
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN® (test product) and NovoRapid® (reference product) in healthy male participants. The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 7 days between dosing. 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).
Protocol Amendment History 3 changes
critical Trial completed 2026-08-15
notable Primary completion moved earlier: 2026-08-10 -> 2026-06-13 2026-08-15
minor Completion moved earlier: 2026-08-10 -> 2026-07-03 2026-08-15
Trial Details
NCT Number NCT07600944
Lead Sponsor Zhuhai United Laboratories Co., Ltd.
Conditions Pharmacokinetics and Pharmacodynamics
Enrollment 44 participants
Start Date 2026-05-06
Primary Completion 2026-06-13 (estimated)
Study Completion 2026-07-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-14