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COMPLETED
NCT07608692
PHASE1

Comparative Clinical Trial of Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

Sponsor: Zhuhai United Laboratories Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Center, Randomized, Double-Blind, Two-Formulation, Single-Dose, Two-Period Crossover Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-08-04

Completion Date

2026-01-13

Last Updated

2026-05-27

Healthy Volunteers

Yes

Interventions

DRUG

Human Insulin Injection(USLIN®R)

a single subcutaneous dose of 0.3 IU/kg

DRUG

Human Insulin Injection(NOVOLIN®R)

a single subcutaneous dose of 0.3 IU/kg

Locations (1)

28 Baofeng Road, Qiaokou District

Wuhan, Hubei, China