drugset / Trial / NCT05576298

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

NCT05576298

Phase 1 Completed 46 enrolled Sunshine Lake Pharma Co., Ltd.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2021-10-08
Primary completion
2022-03-21
Completion
2022-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin degludec Protein / enzyme biologic Subcutaneous