/ CompletedNot Applicable [Translation] Study on the bioequivalence of mesalazine enteric-coated tablets in healthy volunteers
本试验旨在研究单次空腹口服杭州煌森生物科技有限公司持证、浙江京新药业股份有限公司生产的美沙拉秦肠溶片(0.5 g)的药代动力学特征;以Losan Pharma GmbH生产的美沙拉秦肠溶片(莎尔福®,0.5 g)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t,评价两制剂的人体生物等效性。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of a single fasting oral dose of mesalazine enteric-coated tablets (0.5 g) produced by Hangzhou Huangsen Biotechnology Co., Ltd. and Zhejiang Jingxin Pharmaceutical Co., Ltd.; using mesalazine enteric-coated tablets (Salfo®, 0.5 g) produced by Losan Pharma GmbH as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-t of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of mesalazine enteric-coated tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服杭州煌森生物科技有限公司持证、浙江京新药业股份有限公司生产的美沙拉秦肠溶片(0.5 g)的药代动力学特征;以Losan Pharma GmbH生产的美沙拉秦肠溶片(莎尔福®,0.5 g)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t,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 mesalazine enteric-coated tablets (0.5 g) produced by Hangzhou Huangsen Biotechnology Co., Ltd. and Zhejiang Jingxin Pharmaceutical Co., Ltd.; using mesalazine enteric-coated tablets (Salfo®, 0.5 g) produced by Losan Pharma GmbH as the reference preparation, the pharmacokinetic parameters Cmax and AUC0-t of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
/ Not yet recruitingNot Applicable [Translation] Study on the bioequivalence of vonoprazan fumarate tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服杭州煌森生物科技有限公司研制、浙江京新药业股份有限公司生产的富马酸伏诺拉生片(20 mg)的药代动力学特征;以Takeda Pharmaceutical Company Limited生产的富马酸伏诺拉生片(沃克®,20 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 vonoprazan fumarate tablets (20 mg) developed by Hangzhou Huangsen Biotechnology Co., Ltd. and produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.; using vonoprazan fumarate tablets (Walker®, 20 mg) produced by Takeda Pharmaceutical Company Limited as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
100 Clinical Results associated with Hangzhou Huangsen Biotechnology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Huangsen Biotechnology Co., Ltd.
100 Deals associated with Hangzhou Huangsen Biotechnology Co., Ltd.
100 Translational Medicine associated with Hangzhou Huangsen Biotechnology Co., Ltd.