/ CompletedNot Applicable [Translation] Bioequivalence study of iguratimod tablets in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服由海南合瑞制药股份有限公司生产的艾拉莫德片(受试制剂,规格:25mg)与相同条件下单次口服由海南先声药业有限公司持证的艾拉莫德片(参比制剂,商品名:艾得辛®,规格:25mg)的药动学特征,评价两制剂间的生物等效性及安全性,为该受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of Iguratimod tablets (test preparation, specification: 25 mg) produced by Hainan Herui Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of Iguratimod tablets (reference preparation, trade name: Edexin®, specification: 25 mg) certified by Hainan Xiansheng Pharmaceutical Co., Ltd. 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.
/ CompletedNot Applicable 布地奈德肠溶胶囊在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of budesonide enteric-coated capsules in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服由海南合瑞制药股份有限公司提供的布地奈德肠溶胶囊(受试制剂T,规格:4mg)与相同条件下单次口服由Calliditas Therapeutics AB公司持证的布地奈德肠溶胶囊(参比制剂R,商品名:Tarpeyo®,规格:4mg)的药代动力学特征,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 budesonide enteric-coated capsules (test preparation T, specification: 4 mg) provided by Hainan Herui Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of budesonide enteric-coated capsules (reference preparation R, trade name: Tarpeyo®, specification: 4 mg) certified by Calliditas Therapeutics AB 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.
/ CompletedNot Applicable 他克莫司胶囊在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of tacrolimus capsules in fasting and fed subjects
考察健康受试者在空腹及餐后条件下,单次口服由海南合瑞制药股份有限公司生产的他克莫司胶囊(受试制剂,规格:1mg)与相同条件下单次口服由Astellas Pharma Co.Limited公司持证的他克莫司胶囊(参比制剂,商品名:Prograf®,规格:1mg)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 tacrolimus capsules (test preparation, specification: 1 mg) produced by Hainan Herui Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of tacrolimus capsules (reference preparation, trade name: Prograf®, specification: 1 mg) certified by Astellas Pharma Co. Limited 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 Hainan He Rui Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Hainan He Rui Pharmaceutical Co. Ltd.
100 Deals associated with Hainan He Rui Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Hainan He Rui Pharmaceutical Co. Ltd.