NCT05737576

The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

A Single Center, Randomized, Double-Blind, 2-period, 2-sequence Crossover Designed Study to Evaluate the Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	HR011408 injection; NovoRapid®	HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.
DRUG	NovoRapid®；HR011408 injection	NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.
DRUG	HR011408 injection; NovoRapid®	HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.
DRUG	NovoRapid®；HR011408 injection	NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.
DRUG	HR011408 injection; NovoRapid®	HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.
DRUG	HR011408 injection; NovoRapid®	NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.

Timeline

• Start date: 2023-03-20
• Primary completion: 2023-10-26
• Completion: 2023-12-08
• First posted: 2023-02-21
• Last updated: 2024-02-07

Locations

1 site across 1 country: China