[Translation] A randomized, open-label, single-dose, two-period, double-crossover PK/PD study of recombinant human granulocyte-stimulating factor injection 1.0ml:300μg and 1.2ml:300μg in healthy subjects
以1.0mL;300ug的重组人粒细胞刺激因子注射液(rhG-CSF)为受试制剂,按生物等效性试验的有关规定,与1.2mL:300ug的rhG-CSF(参比制剂)进行对比试验,考察单次皮下注射rhG-CSF受试制剂或参比制剂在中国健康受试者体内药代动力学(PK)特征/药效动力学(PD)特征,评价两种规格制剂的生物等效性和安全性。
[Translation] Using 1.0mL; 300ug recombinant human granulocyte-stimulating factor injection (rhG-CSF) as the test preparation, a comparative study was conducted with 1.2mL: 300ug rhG-CSF (reference preparation) in accordance with the relevant provisions of the bioequivalence study, to investigate the pharmacokinetic (PK) characteristics/pharmacodynamic (PD) characteristics of a single subcutaneous injection of the test preparation or the reference preparation of rhG-CSF in Chinese healthy subjects, and to evaluate the bioequivalence and safety of the two preparations.