NCT05719961

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

Bioequivalence Studyof INS062 Injection and NovoRapid ®in Healthy Subjects and Pharmacokinetics and Pharmacodynamics Study of Single Subcutaneous Injection of HR20014 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-05
• Primary completion: 2023-07-01
• Completion: 2023-07-30
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: China