/ CompletedNot Applicable 艾普拉唑肠溶片(规格:5 mg)在餐后状态下健康人体生物等效性研究
[Translation] Bioequivalence study of ilaprazole enteric-coated tablets (5 mg) in healthy volunteers after feeding
主要目的:
本研究以江苏飞马药业有限公司生产并持有的艾普拉唑肠溶片(规格:5mg)为受试制剂,按生物等效性研究的有关规定,以丽珠集团丽珠制药厂持有的艾普拉唑肠溶片(规格:5 mg,商品名:壹丽安®)为参比制剂,评估受试制剂和参比制剂在餐后状态下给药后的生物等效性。
次要目的:
观察受试制剂艾普拉唑肠溶片和参比制剂艾普拉唑肠溶片(壹丽安®)在健康受试者中的安全性。
[Translation] Main purpose:
This study used ilaprazole enteric-coated tablets (specification: 5 mg) produced and owned by Jiangsu Pegasus Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, ilaprazole enteric-coated tablets (specification: 5 mg, trade name: Yilian®) owned by Livzon Pharmaceutical Factory of Livzon Group were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration in the fed state.
Secondary purpose:
Observe the safety of the test preparation ilaprazole enteric-coated tablets and the reference preparation ilaprazole enteric-coated tablets (Yilian®) in healthy subjects.
/ CompletedNot Applicable 艾普拉唑肠溶片(规格:5 mg)在空腹状态下健康人体生物等效性研究
[Translation] Bioequivalence study of ilaprazole enteric-coated tablets (strength: 5 mg) in healthy volunteers under fasting condition
主要目的:
本研究以江苏飞马药业有限公司生产并持有的艾普拉唑肠溶片(规格:5mg)为受试制剂,按生物等效性研究的有关规定,以丽珠集团丽珠制药厂持有的艾普拉唑肠溶片(规格:5 mg,商品名:壹丽安®)为参比制剂,评估受试制剂和参比制剂在空腹状态下给药后的生物等效性。
次要目的:
观察受试制剂艾普拉唑肠溶片和参比制剂艾普拉唑肠溶片(壹丽安®)在健康受试者中的安全性。
[Translation] Main purpose:
This study used ilaprazole enteric-coated tablets (specification: 5 mg) produced and owned by Jiangsu Pegasus Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, ilaprazole enteric-coated tablets (specification: 5 mg, trade name: Yilian®) owned by Livzon Pharmaceutical Factory of Livzon Group were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration in the fasting state.
Secondary purpose:
Observe the safety of the test preparation ilaprazole enteric-coated tablets and the reference preparation ilaprazole enteric-coated tablets (Yilian®) in healthy subjects.
/ CompletedNot Applicable 乌帕替尼缓释片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of upadacitinib extended-release tablets in humans under fasting and fed conditions
本研究考察健康男性和女性受试者在空腹及餐后条件下,单次口服由江苏飞马药业有限公司提供的乌帕替尼缓释片(受试制剂,规格:15mg)与相同条件下单次口服由AbbVie Deutschland GmbH & Co. KG持证的乌帕替尼缓释片(参比制剂,商品名:Rinvoq®,规格:15mg)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] This study investigated the pharmacokinetic characteristics of upadacitinib sustained-release tablets (test preparation, strength: 15 mg) provided by Jiangsu Pegasus Pharmaceutical Co., Ltd. and upadacitinib sustained-release tablets (reference preparation, trade name: Rinvoq®, strength: 15 mg) approved by AbbVie Deutschland GmbH & Co. KG in healthy male and female subjects under fasting and postprandial conditions, and evaluated the bioequivalence and safety of the two preparations to provide a basis for the registration application of the test preparation.
100 Clinical Results associated with Jiangsu Feima Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Feima Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Feima Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Feima Pharmaceutical Co., Ltd.