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Bioequivalence Study of INS062 and Pharmacokinetics and Pharmacokinetics Study of Single Injection of HR20014 in Healthy Subjects

NCT05719961 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-09

No results posted yet for this study

Summary

This study was divided into two parts. The aim of this study is to investigate the bioequivalence of INS062 injection andNovoRapid ® in healthy subjects(Part I), and to investigate the pharmacokinetics and pharmacodynamics of single dose of HR20014 injection and BIAsp 30 in healthy subjects(Part II).

Conditions

Interventions

DRUG

INS062 injection

Part I: A single dose of 1.2noml/kg is administered.

DRUG

Insulin Aspart

Part I: A single dose of 0.2U/kg is administered.

DRUG

HR20014 injection

Part II: Ascending single doses at three dose levels

DRUG

Insulin Aspart 30 Injection

Part II: A single dosewas administered

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2023-07-01
Completion
2023-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05719961 on ClinicalTrials.gov