A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

Summary

To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and Victoza ® in healthy subjects.

Timeline

Start

2020-06-22

Primary completion

2020-07-20

Completion

2020-11-27

Outcome

Met primary endpoint

paper The 90% CIs of the GMR of RD12014 to Victoza for Cmax and AUC0-last were completely within the range of 80.00-125.00%. PMID 35871497 ↗

Publications

• Zhou R, Guo L, Gao X, Wang Y, Xu W, Zou Y, Li W, Zhuang Y, Liu G, Liu Y. A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects. Clin Transl Sci. 2022 Oct;15(10):2458-2467. doi: 10.1111/cts.13374. Epub 2022 Jul 31.

Drugs

Indications