[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, double-crossover bioequivalence study of oral cefcapone hydrochloride granules in Chinese healthy volunteers in the fasting and fed state
主要研究目的
研究空腹和餐后状态下单次口服受试制剂盐酸头孢卡品酯颗粒(规格:50mg(按C17H19N5O6S2计),沐源(安徽)药业有限公司提供)与参比制剂盐酸头孢卡品酯颗粒(规格:10%(1g含盐酸盐水合物100mg,50mg/袋)),商品名:Flomox®,塩野義製薬株式会社持证)在健康成年受试者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下,单次口服受试制剂盐酸头孢卡品酯颗粒和参比制剂盐酸头孢卡品酯颗粒(Flomox®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation Cefuroxime Hydrochloride Granules (Specification: 50mg (calculated as C17H19N5O6S2), provided by Muyuan (Anhui) Pharmaceutical Co., Ltd.) and the reference preparation Cefuroxime Hydrochloride Granules (Specification: 10% (1g contains 100mg hydrochloride hydrate, 50mg/bag)), trade name: Flomox®, certified by Shionogi Pharmaceutical Co., Ltd.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objectives
To evaluate the safety of the test preparation Cefuroxime Hydrochloride Granules and the reference preparation Cefuroxime Hydrochloride Granules (Flomox®) in the fasting and fed state in healthy Chinese subjects.