马来酸奈拉替尼片在健康受试者中空腹/餐后单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence study of neratinib maleate tablets in healthy subjects after single oral administration on an empty stomach or after a meal
主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服郑州德迈药业有限公司的马来酸奈拉替尼片（规格：40mg/片）与持证商Puma Biotechnology Inc.的马来酸奈拉替尼片（规格：40mg/片）后的体内药代动力学特征，评价两制剂的生物等效性。
次要目的：评价单剂量口服马来酸奈拉替尼片240mg（6片，规格：40mg/片）受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of single-dose oral administration of neratinib maleate tablets (specification: 40 mg/tablet) from Zhengzhou Demai Pharmaceutical Co., Ltd. and neratinib maleate tablets (specification: 40 mg/tablet) from Puma Biotechnology Inc., a licensee, in healthy Chinese subjects under fasting/postprandial conditions through fasting/postprandial test studies, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of single-dose oral administration of neratinib maleate tablets 240 mg (6 tablets, specification: 40 mg/tablet) and reference preparations in healthy Chinese subjects.
罗沙司他胶囊在健康受试者中随机、开放、两制剂、单次给药、双周期、双交叉空腹和餐后状态下的生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover bioequivalence study of roxadustat capsules in healthy subjects under fasting and fed conditions
主要目的：以郑州德迈药业有限公司研制的罗沙司他胶囊为受试制剂，以珐博进（中国）医药技术开发有限公司生产的罗沙司他胶囊（商品名：爱瑞卓®）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。
次要目的：评价中国健康受试者单次空腹/餐后口服罗沙司他胶囊受试制剂和参比制剂后的安全性。
[Translation] Main purpose: To use rosuvastatin capsules developed by Zhengzhou Demai Pharmaceutical Co., Ltd. as the test preparation and rosuvastatin capsules (trade name: Aeridro®) produced by FibroGen (China) Pharmaceutical Technology Development Co., Ltd. as the reference preparation, to investigate the pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in fasting and postprandial state, and to evaluate whether the two preparations are bioequivalent.
Secondary purpose: To evaluate the safety of the test preparation and reference preparation of rosuvastatin capsules after single oral administration in fasting/postprandial state in healthy Chinese subjects.
[Translation] Study on the bioequivalence of dapoxetine hydrochloride tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服郑州德迈药业有限公司研制、华润三九众益制药有限公司生产的盐酸达泊西汀片（30 mg）的药代动力学特征；以Berlin-Chemie AG持证、Menarini-Von Heyden GmbH生产的盐酸达泊西汀片（Priligy®，30 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 aim of this study was to investigate the pharmacokinetic characteristics of dapoxetine hydrochloride tablets (30 mg) developed by Zhengzhou Demai Pharmaceutical Co., Ltd. and produced by China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; dapoxetine hydrochloride tablets (Priligy®, 30 mg) certified by Berlin-Chemie AG and produced by Menarini-Von Heyden GmbH were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Zhengzhou Demai Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhengzhou Demai Pharmaceutical Co., Ltd.
100 Deals associated with Zhengzhou Demai Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhengzhou Demai Pharmaceutical Co., Ltd.
