[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of cefixime capsules on an empty stomach or after a meal in healthy volunteers
主要研究目的:
研究空腹和餐后状态下单次口服受试制剂头孢克肟胶囊(规格:0.1g,山东诚康药业有限公司持证)与参比制剂头孢克肟胶囊(Cefspan®,规格:0.1g(按 C16H15N5O7S2 计), Choseido Pharmaceutical Co.,Ltd.持证)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:
空腹和餐后状态下,研究单次口服受试制剂头孢克肟胶囊和参比制剂头孢克肟胶囊(Cefspan ®)在健康成年受试者中的安全性。
[Translation] Main study objectives:
To study the pharmacokinetics of the test preparation cefixime capsule (specification: 0.1g, licensed by Shandong Chengkang Pharmaceutical Co., Ltd.) and the reference preparation cefixime capsule (Cefspan®, specification: 0.1g (calculated as C16H15N5O7S2), licensed by Choseido Pharmaceutical Co., Ltd.) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed state.
Secondary study objectives:
To study the safety of the test preparation cefixime capsule and the reference preparation cefixime capsule (Cefspan®) in healthy adult subjects after single oral administration in fasting and fed state.