[Translation] An open-label, randomized, single-dose, two-course, crossover, bioequivalence study of oral deferasirox granules 360 mg compared with JADENU® granules 360 mg in healthy adults 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(规格:360mg,祐儿医药研发(杭州)有限公司研制,杭州民生药业股份有限公司生产)与参比制剂地拉罗司颗粒(商品名:JADENU® Sprinkle,规格:360mg,Novartis Pharmaceuticals Corp 持证,CatalentGermany Schorndorf GmbH 生产)在健康受试者体内的药代动力学,评价空腹和进食两种状态下口服两种制剂的生物等效性。
次要研究目的:
评价健康受试者在空腹和餐后状态下,单次口服地拉罗司颗粒受试制剂和参比制剂后的安全性和耐受性。
[Translation] Main research purposes:
To study the single oral administration of the test preparation (specification: 360 mg, developed by Youer Pharmaceutical R&D (Hangzhou) Co., Ltd. and produced by Hangzhou Minsheng Pharmaceutical Co., Ltd.) and the reference preparation deferasirox granules (trade name) in fasting and postprandial states. : JADENU® Sprinkle, strength: 360mg, licensed by Novartis Pharmaceuticals Corp, produced by CatalentGermany Schorndorf GmbH) pharmacokinetics in healthy subjects, to evaluate the bioequivalence of the two oral preparations in fasting and fed states.
Secondary research purpose:
To evaluate the safety and tolerability of healthy subjects after a single oral administration of deferasirox granules test preparation and reference preparation under fasting and postprandial conditions.