[Translation] A single-dose, randomized, open-label, two-period, two-sequence, self-crossover bioequivalence study of liraglutide injection in healthy subjects under fasting condition
主要研究目的 研究空腹状态下单次皮下注射受试制剂利拉鲁肽注射液(规格:3 mL:18 mg,江苏诺泰澳赛诺生物制药股份有限公司)与参比制剂利拉鲁肽注射液(商品名:诺和力,规格:3 mL:18 mg,丹麦诺和诺德公司/Novo Nordisk A/S)在健康成年受试者体内的药代动力学,评价两制剂生物等效性。 次要研究目的 评价健康受试者空腹单次皮下注射受试制剂(T)利拉鲁肽注射液和参比制剂(R)利拉鲁肽注射液(诺和力)后的安全性。
[Translation] Primary study objective To investigate the pharmacokinetics of a single subcutaneous injection of the test preparation liraglutide injection (specification: 3 mL:18 mg, Jiangsu Notai Ausino Biopharmaceutical Co., Ltd.) and the reference preparation liraglutide injection (trade name: Victoza, specification: 3 mL:18 mg, Novo Nordisk A/S, Denmark) in healthy adult subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary study objective To evaluate the safety of a single subcutaneous injection of the test preparation (T) liraglutide injection and the reference preparation (R) liraglutide injection (Victoza) in healthy subjects under fasting conditions.