[Translation] Randomized, open-label, single-dose, two-preparation, single-dose, cross-controlled bioequivalence study of erythromycin ethylsuccinate tablets in healthy subjects under fasting and postprandial conditions
主要目的:研究空腹及餐后状态下单次口服受试制剂琥乙红霉素片(规格:0.4g,浙江恒研医药科技有限公司研制,浙江赛默制药有限公司生产)与参比制剂琥乙红霉素片(商品名:E.E.S.400®,规格:400mg,ARBOR PHARMACEUTICALS LLC持证)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性。
[Translation] Main purpose: To study the difference between the test preparation Erythromycin Ethyl Succinate Tablets (specification: 0.4g, developed by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd. and produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation Erythromycin Ethyl Succinate in the fasting and postprandial state. Pharmacokinetics of erythromycin tablets (trade name: E.E.S.400®, strength: 400mg, licensed by ARBOR PHARMACEUTICALS LLC) in healthy adult subjects, and the bioequivalence of the two preparations taken orally under fasting and postprandial conditions were evaluated. effectiveness.