[Translation] A single-center, randomized, open-label, two-dose, single-dose, parallel-design comparative study to evaluate the PK of semaglutide injection in healthy Chinese subjects
主要目的: 以 Novo Nordisk A/S 生产的司美格鲁肽注射液(商品名:诺和泰®)为参照药,以浙江普洛康裕制药有限公司提供的司美格鲁肽注射液为试验药,通过单中心、随机、开放、两制剂、单次给药、平行设计的 PK 比较研究,评估皮下注射两种制剂在中国健康受试者体内的药代动力学相似性。 次要目的: 评价两种制剂在中国健康受试者中的安全性和免疫原性。
[Translation] Primary objective: Using semaglutide injection (trade name: Novo Nordisk®) produced by Novo Nordisk A/S as the reference drug and semaglutide injection provided by Zhejiang Proconyu Pharmaceutical Co., Ltd. as the test drug, a single-center, randomized, open, two-formulation, single-dose, parallel-design PK comparative study was conducted to evaluate the pharmacokinetic similarity of the two formulations in healthy Chinese subjects after subcutaneous injection. Secondary objective: To evaluate the safety and immunogenicity of the two formulations in healthy Chinese subjects.