[Translation] A single-dose, randomized, open-label, two-period, two-crossover, fasting bioequivalence study of liraglutide injection in healthy subjects
以成都圣诺生物制药有限公司研制的利拉鲁肽注射液(规格:3mL:18mg)为受试制 剂(T),诺和诺德(中国)制药有限公司生产的利拉鲁肽注射液(商品名:诺和力 ®,规格:3mL:18mg)为参比制剂(R),研究受试制剂和参比制剂在健康受试者空 腹状态下单剂量给药时的药代动力学参数,初步进行两种制剂的人体生物等效性评 价。
[Translation] Liraglutide injection (specification: 3mL:18mg) developed by Chengdu Shengnuo Biopharmaceutical Co., Ltd. was used as the test preparation (T), and liraglutide injection (trade name: Novoligy®, specification: 3mL:18mg) produced by Novo Nordisk (China) Pharmaceuticals Co., Ltd. was used as the reference preparation (R). The pharmacokinetic parameters of the test preparation and the reference preparation were studied when administered as a single dose in healthy volunteers under fasting state, and the human bioequivalence of the two preparations was preliminarily evaluated.