[Translation] Single-center evaluation of the test formulation Cefaclor Extended-Release Tablets (II) (strength: 0.375 g) and the reference formulation (Ceccor®) (strength: 0.375 g) in healthy adult subjects in the fasting and postprandial states , 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克洛缓释片(II)(规格:0.375 g,金鸿药业股份有限公司生产)与参比制剂头孢克洛缓释片(II)(希刻劳®,规格:0.375 g,苏州西克罗制药有限公司生产)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:研究受试制剂头孢克洛缓释片(II)(规格:0.375 g)和参比制剂头孢克洛缓释片(II)(希刻劳®,规格:0.375 g)在健康受试者中的安全性。
[Translation] Main test purpose: To study the effect of single oral administration of test preparation cefaclor sustained-release tablets (II) (specification: 0.375 g, produced by Jinhong Pharmaceutical Co., Ltd.) and reference preparation cefaclor sustained-release in fasting and postprandial states. Tablet (II) (Ciclor®, specification: 0.375 g, produced by Suzhou Ciclo Pharmaceutical Co., Ltd.) in healthy subjects. Pharmacokinetic characteristics, evaluation of the biology of the two preparations in fasting and postprandial states, etc. effectiveness.
Secondary trial purpose: To study the test preparation cefaclor sustained-release tablets (II) (strength: 0.375 g) and the reference preparation cefaclor sustained-release tablets (II) (Ciclor®, strength: 0.375 g) in healthy Safety in Subjects.