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

StatusNot Yet Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
The present study is designed to compare the pharmacokinetic, pharmacodynamic and safety characteristics of UBLIN 30® (test product) and NovoMix®30 (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 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).
Trial Details
NCT Number NCT07875803
Lead Sponsor Zhuhai United Laboratories Co., Ltd.
Conditions
(from sponsor)		 Pharmacokinetics and Pharmacodynamics
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov