[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation bemiparheparin sodium injection (0.2 mL: 3500 IU (anti-Xa)) versus the reference formulation (Xiabao®) (0.2 mL: 3500 IU (anti-Xa)) in healthy adult participants under fasting conditions.
主要试验目的: 研究空腹状态下单次皮下注射受试制剂贝米肝素钠注射液(规格: 0.2mL: 3500AXaIU, 烟台东诚北方制药有限公司生产)与参比制剂贝米肝素钠注射液( 稀保®,规格: 0.2mL: 3500IU(抗 Xa) ; ROVI PHARMA INDUSTRIAL SERVICES, S.A.生产)在健康参与者体内的药效学特征,评价空腹状态皮下注射两种制剂的生物等效性。
次 要 试 验 目 的 :研 究受 试 制 剂 贝 米 肝素 钠注 射 液 ( 规 格 : 0.2mL:3500AXaIU) 和参比制剂贝米肝素钠注射液(稀保®) (规格: 0.2mL: 3500IU(抗 Xa) ) 在健康参与者中的安全性。
[Translation] Main objective: To investigate the pharmacodynamic characteristics of a single subcutaneous injection of the test formulation, bemiparin sodium injection (0.2 mL: 3500 Xa IU, manufactured by Yantai Dongcheng Northern Pharmaceutical Co., Ltd.), and the reference formulation, bemiparin sodium injection (Xibao®, 0.2 mL: 3500 IU (anti-Xa); manufactured by ROVI PHARMA INDUSTRIAL SERVICES, S.A.), in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting subcutaneous injection.
Secondary objective: To investigate the safety of the test formulation, bemiheparin sodium injection (specification: 0.2 mL: 3500 IU Xa), and the reference formulation, bemiheparin sodium injection (Xiabao®) (specification: 0.2 mL: 3500 IU (anti-Xa)), in healthy participants.