[Translation] Preliminary study on bioequivalence of teprenone capsules in human body
本试验为预试验，旨在研究单次空腹和餐后口服杭州沐源生物医药科技有限公司研制、成都通德药业有限公司生产的替普瑞酮胶囊（50 mg）的药代动力学特征；以卫材（中国）药业有限公司生产的替普瑞酮胶囊（50 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，为正式试验的开展提供参考。
[Translation] This study is a pilot study, aimed at studying the pharmacokinetic characteristics of a single fasting and postprandial oral administration of teprenone capsules (50 mg) developed by Hangzhou Muyuan Biotechnology Co., Ltd. and produced by Chengdu Tongde Pharmaceutical Co., Ltd.; using teprenone capsules (50 mg) produced by Eisai (China) Pharmaceuticals Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to provide a reference for the formal trial.
[Translation] Bioequivalence study of metoclopramide tablets in human subjects
主要目的：采用单中心、随机、开放、两制剂、双周期交叉、单剂量、空腹及餐后给药设计，比较空腹及餐后给药条件下，杭州沐源生物医药科技有限公司提供的甲氧氯普胺片（规格：10 mg）与ANI PHARMACEUTICALS INC持证的甲氧氯普胺片（商品名：Reglan®，规格：10 mg）在中国健康人群中吸收程度和吸收速度的差异，评价生物等效性。
次要目的：
评价空腹及餐后条件下，杭州沐源生物医药科技有限公司提供的甲氧氯普胺片（规格：10 mg）与ANI PHARMACEUTICALS INC持证的甲氧氯普胺片（商品名：Reglan®，规格：10 mg）的安全性。
[Translation] Primary objective: To compare the differences in the degree and rate of absorption of metoclopramide tablets (specification: 10 mg) provided by Hangzhou Muyuan Biopharmaceutical Technology Co., Ltd. and metoclopramide tablets (trade name: Reglan®, specification: 10 mg) licensed by ANI PHARMACEUTICALS INC in healthy Chinese population under fasting and postprandial administration conditions using a single-center, randomized, open, two-dose, two-period crossover, single-dose, fasting and postprandial administration design, and to evaluate bioequivalence.
Secondary objective:
To evaluate the safety of metoclopramide tablets (specification: 10 mg) provided by Hangzhou Muyuan Biopharmaceutical Technology Co., Ltd. and metoclopramide tablets (trade name: Reglan®, specification: 10 mg) licensed by ANI PHARMACEUTICALS INC under fasting and postprandial conditions.
[Translation] Bioequivalence study of benzbromarone tablets in human body
采用单中心、随机、开放、两周期交叉、单剂量给药设计比较空腹和餐后给药条件下，沐源（安徽）药业有限公司提供的苯溴马隆片（规格：50 mg）与トーアエイヨー株式会社持证的苯溴马隆片（商品名：Urinorm®，规格：50 mg）在中国健康人群中吸收程度和吸收速度的差异，并评价沐源（安徽）药业有限公司提供的苯溴马隆片（规格：50 mg）的安全性。
[Translation] A single-center, randomized, open, two-period crossover, single-dose design was used to compare the differences in absorption extent and absorption rate between benzbromarone tablets (specification: 50 mg) provided by Muyuan (Anhui) Pharmaceutical Co., Ltd. and benzbromarone tablets (trade name: Urinorm®, specification: 50 mg) certified by Toeiyo Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of benzbromarone tablets (specification: 50 mg) provided by Muyuan (Anhui) Pharmaceutical Co., Ltd.
100 Clinical Results associated with Hangzhou Muyuan Biomedical Technology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Muyuan Biomedical Technology Co., Ltd.
100 Deals associated with Hangzhou Muyuan Biomedical Technology Co., Ltd.
100 Translational Medicine associated with Hangzhou Muyuan Biomedical Technology Co., Ltd.
