[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test product, Cefaclor Extended Release Tablets (II) (strength: 0.375 g), and the reference product (Cefaclor®) (strength: 0.375 g) in healthy adult subjects under fasting and fed conditions.
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] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Cefaclor Sustained-Release Tablets (II) (Specification: 0.375 g, produced by Jinhong Pharmaceutical Co., Ltd.) and the reference preparation Cefaclor Sustained-Release Tablets (II) (Ceclaro®, Specification: 0.375 g, produced by Suzhou Cecro Pharmaceutical Co., Ltd.) 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.
Secondary purpose of the study: to study the safety of the test preparation Cefaclor Sustained-Release Tablets (II) (Specification: 0.375 g) and the reference preparation Cefaclor Sustained-Release Tablets (II) (Ceclaro®, Specification: 0.375 g) in healthy subjects.