[Translation] A randomized, open-label, single-dose, two-formulation, parallel pharmacokinetic comparison study of semaglutide injection in healthy subjects
主要目的:评价在空腹状态下,单次皮下注射0.25mg试验药(T)司美格鲁肽注射液(宜昌人福药业有限责任公司提供,规格:1.34mg/ml,1.5ml)与0.25mg参照药(R)司美格鲁肽注射液(Novo Nordisk A/S生产,商品名:诺和泰,规格:1.34 mg/ mL,1.5 ml)在健康成年受试者体内的药代动力学特征的相似性。
次要目的:评价试验药司美格鲁肽注射液与参照药(诺和泰)在健康成年受试者中的免疫原性与安全性。
[Translation] Primary objective: To evaluate the similarity of the pharmacokinetic characteristics of a single subcutaneous injection of 0.25 mg of the investigational drug (T) semaglutide injection (provided by Yichang Renfu Pharmaceutical Co., Ltd., specification: 1.34 mg/ml, 1.5 ml) and 0.25 mg of the reference drug (R) semaglutide injection (produced by Novo Nordisk A/S, trade name: Novotec, specification: 1.34 mg/ mL, 1.5 ml) in healthy adult subjects under fasting conditions.
Secondary objective: To evaluate the immunogenicity and safety of the investigational drug semaglutide injection and the reference drug (Novotec) in healthy adult subjects.