/ CompletedNot Applicable [Translation] Study on the bioequivalence of tranexamic acid tablets in healthy volunteers
主要目的:
比较空腹及餐后给药条件下,宁波美诺华天康药业有限公司提供的氨甲环酸片(规格:0.5 g)与DAIICHI SANKYO CO.,LTD.(第一三共株式会社)持证氨甲环酸片(商品名:妥塞敏®/Transamin®;规格:0.5 g)在健康人群中吸收程度和速度的差异。
次要目的:
评价空腹及餐后给药条件下,宁波美诺华天康药业有限公司提供的氨甲环酸片(规格:0.5 g)与DAIICHI SANKYO CO.,LTD.(第一三共株式会社)持证氨甲环酸片(商品名:妥塞敏®/Transamin®;规格:0.5 g)的安全性。
[Translation] Primary objective:
To compare the differences in absorption degree and speed between tranexamic acid tablets (specification: 0.5 g) provided by Ningbo Mennova Tiankang Pharmaceutical Co., Ltd. and certified tranexamic acid tablets (trade name: Tosamine®/Transamin®; specification: 0.5 g) of Daiichi Sankyo Co., Ltd. in healthy people under fasting and postprandial administration conditions.
Secondary objective:
To evaluate the safety of tranexamic acid tablets (specification: 0.5 g) provided by Ningbo Mennova Tiankang Pharmaceutical Co., Ltd. and certified tranexamic acid tablets (trade name: Tosamine®/Transamin®; specification: 0.5 g) of Daiichi Sankyo Co., Ltd. under fasting and postprandial administration conditions.
/ CompletedNot Applicable [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宁波美诺华天康药业有限公司研制、江苏华阳制药有限公司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 trial aims to study the pharmacokinetic characteristics of ibrutinib capsules (140 mg) developed by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. and produced by Jiangsu Huayang Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration 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.
/ CompletedNot Applicable 枸橼酸托法替布缓释片在健康受试者中随机、开放、两制剂、两周期、双交叉空腹及餐后条件下的生物等效性试验
[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of tofacitinib citrate extended-release tablets in healthy subjects under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服由宁波美诺华天康药业有限公司提供的枸橼酸托法替布缓释片(受试制剂,规格:11mg)与相同条件下单次口服由Pfizer Inc.持证的枸橼酸托法替布缓释片(参比制剂,商品名:Xeljanz®/尚杰,规格:11mg)的药动学特征,评价两制剂间的生物等效性和安全性,为该受试制剂注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of tofacitinib citrate sustained-release tablets (test preparation, specification: 11 mg) provided by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, and a single oral administration of tofacitinib citrate sustained-release tablets (reference preparation, trade name: Xeljanz®/Shangjie, specification: 11 mg) certified by Pfizer Inc. under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.
100 Clinical Results associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.
100 Deals associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Ningbo Menovo TianKang Pharmaceutical Co., Ltd.