[Translation] A single-center, randomized, open-label, two-formulation, two-period, two-sequence, single-dose, double-crossover bioequivalence study of everolimus tablets in Chinese healthy subjects under fasting and fed conditions
主要研究目的:以依维莫司的主要药代动力学参数(AUC0-t、AUC0-∞和Cmax)为生物等效性的评价指标,在中国健康受试者空腹和餐后状态下评估受试制剂(杭州华东医药集团康润制药有限公司委托杭州华东医药集团浙江华义制药有限公司生产的依维莫司片,规格5mg)和参比制剂(持证商为Novartis Pharma Schweiz AG,生产企业为Novartis Pharma Stein AG的依维莫司片,规格5mg,商品名:飞尼妥®/Afinitor®)的生物等效性。次要研究目的:观察空腹和餐后状态下口服受试制剂和参比制剂的安全性。
[Translation] The main study objectives are to evaluate the bioequivalence of the test preparation (everolimus tablets, 5 mg, produced by Hangzhou Huadong Medicine Group Zhejiang Huayi Pharmaceutical Co., Ltd. and commissioned by Hangzhou Huadong Medicine Group Kangrun Pharmaceutical Co., Ltd.) and the reference preparation (everolimus tablets, 5 mg, trade name: Afinitor®, manufactured by Novartis Pharma Schweiz AG and Novartis Pharma Stein AG, with the main pharmacokinetic parameters of everolimus (AUC0-t, AUC0-∞ and Cmax) as bioequivalence evaluation indicators in Chinese healthy subjects under fasting and fed conditions. The secondary study objectives are to observe the safety of oral administration of the test preparation and the reference preparation under fasting and fed conditions.