[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of cefcapone hydrochloride granules in healthy subjects
以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂盐酸头孢卡品酯颗粒(规格:50mg(按C17H19N5O6S2计),持证商:苏州盛达药业有限公司)与参比制剂盐酸头孢卡品酯颗粒(规格:50mg(按C17H19N5O6S2计),持证商:SHIONOGI & Co., LTD.)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
[Translation] Pharmacokinetic parameters were used as the primary endpoint evaluation indicators. The pharmacokinetic behaviors of the test preparation Cefcapone Hydrochloride Granules (Specification: 50 mg (calculated as C17H19N5O6S2), license holder: Suzhou Shengda Pharmaceutical Co., Ltd.) and the reference preparation Cefcapone Hydrochloride Granules (Specification: 50 mg (calculated as C17H19N5O6S2), license holder: SHIONOGI & Co., LTD.) in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations.