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Comparative Clinical Trial of Pharmacokinetics and Pharmacodynamics of Human Insulin Injection

NCT07608692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics and Pharmacodynamics

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

Sponsors & Collaborators

  • Zhuhai United Laboratories Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2025-11-25
Completion
2026-01-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608692 on ClinicalTrials.gov