/ CompletedNot Applicable 磷酸芦可替尼片在中国健康受试者中随机、开放、单次给药、两制剂、两周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of ruxolitinib phosphate tablets in Chinese healthy subjects under fasting and fed conditions
主要目的:评价湖北广济医药科技有限公司的磷酸芦可替尼片(受试制剂,规格:5mg;重庆博腾药业有限公司生产)与Novartis Pharma Stein AG,瑞士生产的磷酸芦可替尼片(参比制剂,规格:5mg,商品名:Jakavi(捷恪卫))在中国健康受试者中空腹/餐后单次给药(5mg)条件下的药代动力学特征,评价受试制剂和参比制剂的生物等效性。
次要目的:评价中国健康受试者空腹和餐后条件下单次服用5mg受试制剂磷酸芦可替尼片和5mg参比制剂磷酸芦可替尼片(Jakavi(捷恪卫))的安全性。
[Translation] Primary objective: To evaluate the pharmacokinetic characteristics of ruxolitinib phosphate tablets (test preparation, specification: 5 mg; produced by Chongqing Boteng Pharmaceutical Co., Ltd.) produced by Hubei Guangji Pharmaceutical Technology Co., Ltd. and ruxolitinib phosphate tablets (reference preparation, specification: 5 mg, trade name: Jakavi) produced by Novartis Pharma Stein AG, Switzerland under the conditions of single fasting/fed administration (5 mg) in healthy Chinese subjects, and to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary objective: To evaluate the safety of single administration of 5 mg test preparation ruxolitinib phosphate tablets and 5 mg reference preparation ruxolitinib phosphate tablets (Jakavi) under fasting and fed conditions in healthy Chinese subjects.
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