NCT05576298

A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects

Pharmacokinetics, Pharmacodynamic, Safety and Immunogenicity Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection ( Tresiba®）in Healthy Subjects: a Phase I Single-center, Randomized, Open-label, Single-dose, Cross-over Clinical Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Months – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine Biopharmaceutical R\&D Co., Ltd. (RD15003) pharmacokinetics and pharmacodynamic characteristics in healthy subjects, and then to evaluate the bioequivalence of test drugs and control drugs.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Insulin degludec injection, RD15003	single dose, s.c. injection
BIOLOGICAL	Insulin degludec, Tresiba	single dose, s.c. injection

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2022-10-12
• Last updated: 2022-10-12

Locations

1 site across 1 country: China