[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, Cefprozil Tablets (strength: 500 mg), and the reference preparation (strength: 500 mg) in healthy adult subjects in the fasting and fed state.
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] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Cefprozil Tablets (Specification: 500mg, produced by Shantou Jinshi Pharmaceutical Co., Ltd. of Sinopharm Group) and the reference preparation Cefprozil Tablets (Specification: 500mg; produced by Lupin Limited) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. The secondary purpose of the study is to study the safety of the test preparation Cefprozil Tablets (Specification: 500mg) and the reference preparation Cefprozil Tablets (Specification: 500mg) in healthy subjects.