富马酸伏诺拉生片在中国健康受试者中随机、开放、两制剂、两周期、双交叉、空腹/餐后状态下的生物等效性研究
[Translation] Bioequivalence study of raw vonola fumarate tablets in Chinese healthy subjects under randomized, open-label, two-drug, two-period, double-crossover, fasting/fed states
本试验旨在研究单次空腹和餐后口服重庆迪康长江制药有限公司研制、生产的富马酸伏诺拉生片(20 mg)的药代动力学特征;以Takeda Pharmaceutical Company Limited生产的富马酸伏诺拉生片(Vocinti®,20 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of Fumarate Fumarate Tablets (20 mg) developed and produced by Chongqing Dikang Changjiang Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach and after a meal; Vocinti® maleate tablet (Vocinti®, 20 mg) was used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the human bioequivalence of the two preparations.
阿莫西林胶囊在健康受试者中的随机、开放、单剂量、两周期、双交叉空腹和餐后生物等效性试验
[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover fasting and postprandial bioequivalence trial of amoxicillin capsules in healthy subjects
以重庆迪康长江制药有限公司生产的阿莫西林胶囊(规格:250 mg)为受试制剂,Beecham Group plc的阿莫西林胶囊(商品名:Amoxil;规格:250 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
[Translation] The amoxicillin capsules (specification: 250 mg) produced by Chongqing Dikang Changjiang Pharmaceutical Co., Ltd. were used as the test preparation, and the amoxicillin capsules (trade name: Amoxil; specification: 250 mg) produced by Beecham Group plc were used as the reference preparations. The pharmacokinetic parameters and relative bioavailability of a single dose of the two preparations in fasting and postprandial states were used to evaluate whether the two preparations were bioequivalent.
100 Clinical Results associated with Chongqing Dikang Changjiang Pharmaceutical Co., Ltd.
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100 Deals associated with Chongqing Dikang Changjiang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Chongqing Dikang Changjiang Pharmaceutical Co., Ltd.