[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-cycle, double-crossover pharmacokinetic comparison study of liraglutide injection in healthy volunteers under fasting conditions
主要目的:以深圳市健翔生物制药有限公司生产的利拉鲁肽注射液为受试制剂,以丹麦诺和诺德公司生产的利拉鲁肽注射液(商品名:诺和力®)为参比制剂,在健康志愿者中进行药代动力学比对研究,评估两者的药代动力学特征的相似性。
次要目的:评估健康志愿者单次注射受试制剂和参比制剂(商品名:诺和力®)的免疫原性和安全性的相似性。
[Translation] Main purpose: To conduct a pharmacokinetic comparison study in healthy volunteers using liraglutide injection produced by Shenzhen Jianxiang Biopharmaceutical Co., Ltd. as the test preparation and liraglutide injection (trade name: Novo®) produced by Novo Nordisk of Denmark as the reference preparation to evaluate the similarity of their pharmacokinetic characteristics.
Secondary purpose: To evaluate the similarity of immunogenicity and safety of a single injection of the test preparation and the reference preparation (trade name: Novo®) in healthy volunteers.