[Translation] To evaluate the single-center, open-label, randomized, single-dose, two-cycle, two-sequence, single-center, open-label, randomized, single-dose, two-cycle, two-sequence, Crossover Bioequivalence Study
主要试验目的:研究空腹和餐后状态下单次口服受试制剂头孢丙烯片(规格:500mg,国药集团汕头金石制药有限公司生产)与参比制剂头孢丙烯片(Cefprozil Tablets,规格:500mg;Lupin Limited生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。 次要试验目的:研究受试制剂头孢丙烯片(规格:500mg)和参比制剂头孢丙烯片(Cefprozil Tablets)(规格:500mg)在健康受试者中的安全性。
[Translation] Main test purpose: To study the test preparation Cefprozil Tablets (specification: 500mg, produced by Sinopharm Shantou Jinshi Pharmaceutical Co., Ltd.) and the reference preparation Cefprozil Tablets (Cefprozil Tablets, specification: 500mg; Lupin Tablets, specification: 500mg; Limited) pharmacokinetic profile in healthy subjects to evaluate the bioequivalence of the two oral formulations in the fasted and fed states. Secondary trial purpose: To study the safety of test preparation Cefprozil Tablets (strength: 500mg) and reference preparation Cefprozil Tablets (strength: 500mg) in healthy subjects.