[Translation] A randomized, open-label, single-dose, double-crossover phase I clinical study comparing liraglutide injection and Victoza® in healthy subjects
主要研究目的:本研究以北京诺博特生物科技有限公司生产的利拉鲁肽注射液(3ml:18mg)为受试制剂(T),以原研厂家丹麦诺和诺德公司生产的利拉鲁肽注射液(3ml:18mg,商品名:诺和力®)为参比制剂(R),评价受试制剂(T)和参比制剂(R)药代动力学的相似性。
次要研究目的:观察受试制剂(T)和参比制剂(R)在健康受试者中的安全性和免疫原性。
[Translation] Main research purpose: This study uses liraglutide injection (3ml: 18mg) produced by Beijing Nobot Biotechnology Co., Ltd. as the test preparation (T), and liraglutide injection (3ml: 18mg, trade name: Novo®) produced by the original manufacturer Novo Nordisk of Denmark as the reference preparation (R) to evaluate the pharmacokinetic similarity of the test preparation (T) and the reference preparation (R).
Secondary research purpose: To observe the safety and immunogenicity of the test preparation (T) and the reference preparation (R) in healthy subjects.