Status: Recruiting
Comparison of the Pharmacokinetics （PK）and Pharmacodynamics （PD）Biosimilarity of Insulin Aspart Injections After Single-Dose Subcutaneous Administration to Healthy Volunteers
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).
Participants needed: 44
Trial details
Age: 18-55Biological sex: MaleType: InterventionalSponsor: Zhuhai United Laboratories Co., Ltd.Updated: May 22, 2026Locations: 1
Eligibility criteria
Healthy male participants aged 18 to 55 years (inclusive). [+4]
History of specific allergies (e.g., asthma, urticaria, eczema), or those allerg... [+24]