[Translation] An open-label, randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence study of nadroparin calcium injection in healthy subjects
以华北制药华坤河北生物技术有限公司的那屈肝素钙注射液(华北制药金坦生物技术股份有限公司生产)为受试制剂,以ASPEN Notre Dame de Bondeville 生产的那屈肝素钙注射液(速碧林®)为参比制剂,按生物等效性试验的相关规定,比较那屈肝素钙注射液在中国健康受试者体内的药效动力学行为,评价两种制剂的生物等效性,以及安全性。
[Translation] Nadroparin Calcium Injection (produced by North China Pharmaceutical Jintan Biotechnology Co., Ltd.) from Huakun Hebei Biotechnology Co., Ltd. of North China Pharmaceutical Co., Ltd. Bilin®) is the reference preparation. According to the relevant regulations of the bioequivalence test, the pharmacodynamic behavior of Nadroparin Calcium Injection in Chinese healthy subjects was compared, and the bioequivalence of the two preparations was evaluated. and security.