[Translation] Comparative study on the pharmacokinetics of liraglutide injection in healthy volunteers in a single-center, randomized, open-label, single-dose, two-preparation, two-cycle, double-crossover fasting state
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: Take liraglutide injection produced by Shenzhen Jianxiang Bio-Pharmaceutical Co., Ltd. as the test preparation, and take liraglutide injection (trade name: NovoLi®) produced by Denmark Novo Nordisk as the test preparation. For the reference preparation, a pharmacokinetic comparison study was conducted in healthy volunteers to evaluate the similarity of the pharmacokinetic characteristics of the two.
Secondary objective: To evaluate the similarity of the immunogenicity and safety of a single injection of the test preparation and the reference preparation (trade name: Novolith®) in healthy volunteers.