[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover fasting and fed bioequivalence study of faropenem sodium tablets in healthy subjects
本试验旨在研究健康受试者单次空腹和餐后口服海南海灵化学制药有限公司研制、生产的法罗培南钠片(200 mg)的药代动力学特征;以Maruho Co., Ltd持证、生产的法罗培南钠片(Farom®,200 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of faropenem sodium tablets (200 mg) developed and produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration in healthy subjects; Faropenem sodium tablets (Farom®, 200 mg) licensed and produced by Maruho Co., Ltd were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.