[Translation] Study on the bioequivalence of ibrutinib capsules in healthy volunteers
本试验旨在研究健康受试者单次空腹和餐后口服浙江诺得药业有限公司研制、生产的伊布替尼胶囊(140 mg)的药代动力学特征;以Janssen-Cilag International NV持证的伊布替尼胶囊(亿珂®,140 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,并观察两制剂在健康受试者中的安全性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of ibrutinib capsules (140 mg) developed and produced by Zhejiang Nord Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal in healthy subjects; using ibrutinib capsules (Yike®, 140 mg) certified by Janssen-Cilag International NV as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the human bioequivalence of the two preparations was evaluated, and the safety of the two preparations in healthy subjects was observed.
[Translation] Study on the bioequivalence of Asartan potassium tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服浙江诺得药业有限公司研制、生产的美阿沙坦钾片(80 mg)的药代动力学特征;以Takeda Pharma A/S持证、Takeda Ireland Ltd.生产的美阿沙坦钾片(易达比®,80 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] This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of Asartan Potassium Tablets (80 mg) developed and produced by Zhejiang Nord Pharmaceutical Co., Ltd.; using Asartan Potassium Tablets (Edabib®, 80 mg) licensed by Takeda Pharma A/S and produced by Takeda Ireland Ltd. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
[Translation] Study on the bioequivalence of apalutamide tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服浙江诺得药业有限公司研制、生产的阿帕他胺片(60 mg)的药代动力学特征;以Janssen Ortho,LLC生产的阿帕他胺片(安森珂®,60 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-72,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of apalutamide tablets (60 mg) developed and produced by Zhejiang Nord Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Using apalutamide tablets (Ansenke®, 60 mg) produced by Janssen Ortho, LLC as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
100 Clinical Results associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Deals associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.