Comparative Clinical Trial of Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

A study of Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection,in Wuhan Pulmonary Hospital (Wuhan Tuberculosis Prevention and Control Institute).To compare the pharmacokinetic and pharmacodynamics properties of a single subcutaneous dose of the human insulin injection (USLIN®R, Zhuhai United Laboratories (Zhongshan) Co., Ltd.) with the reference product (Novolin®R, Novo Nordisk Inc.) in healthy male subjects,and to evaluate the safety, tolerability, and immunogenicity of the test formulation versus the reference formulation in healthy male subjects.This single-center, randomized, double-blind, two-formulation, single-dose, two-period crossover study will enroll 32 healthy male subjects randomized 1:1 into two sequence groups (A/B, group A is administered in the sequence of T-R, while group B is in R-T). To evaluate the pharmacokinetic and pharmacodynamic properties of the test preparation and the control preparation in healthy male subjects. Each subject will receive single doses of both test and reference formulations across two periods (with ≥14-day washout), following the predefined sequence allocation table. After completing period 2 pharmacokinetic blood sampling, subjects will administer assigned insulin TID for two consecutive days to assess test-reference immunogenicity differences.

NCT Number	NCT07608692
Lead Sponsor	Zhuhai United Laboratories Co., Ltd.
Conditions	Pharmacokinetics and Pharmacodynamics
Enrollment	32 participants
Start Date	2025-08-04
Primary Completion	2025-11-25 (estimated)
Study Completion	2026-01-13 (estimated)
Updated on ClinicalTrials.gov	2026-06-01