/ Not yet recruitingNot Applicable 头孢托仑匹酯颗粒在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of cefditoren pivoxil granules 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1袋由沐源（安徽）药业有限公司提供的头孢托仑匹酯颗粒【受试制剂，规格：50mg（按C19H18N6O5S3计）】与单次口服1袋由Meiji Seika Pharma Co., Ltd.公司持证的头孢托仑匹酯颗粒【参比制剂，商品名：美爱克®，规格：50mg（效价）/0.5g/袋】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 one bag of Cefditoren Pivoxil Granules [test preparation, specification: 50 mg (calculated as C19H18N6O5S3)] provided by Muyuan (Anhui) Pharmaceutical Co., Ltd. and a single oral administration of one bag of Cefditoren Pivoxil Granules [reference preparation, trade name: Mei Aike®, specification: 50 mg (potency)/0.5 g/bag] certified by Meiji Seika Pharma Co., Ltd. in healthy subjects under fasting and postprandial 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 [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.
/ CompletedNot Applicable [Translation] Bioequivalence study of rosuvastatin ezetimibe tablets (I) in healthy volunteers
主要目的：本试验旨在研究单次空腹和餐后口服沐源（安徽）药业有限公司研制、新乡市常乐制药有限责任公司生产的瑞舒伐他汀依折麦布片（I）（10 mg/10 mg）的药代动力学特征；以Sanofi-Aventis France持证、Sanofi Winthrop Industrie-Tours生产的瑞舒伐他汀依折麦布片（I）（SUVREZA®，10 mg/10 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。
次要目的：观察健康受试者单次空腹和餐后口服受试制剂和参比制剂后的安全性。
[Translation] Primary objective: This study aims to study the pharmacokinetic characteristics of rosuvastatin ezetimibe tablets (I) (10 mg/10 mg) developed by Muyuan (Anhui) Pharmaceutical Co., Ltd. and produced by Xinxiang Changle Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; Rosuvastatin ezetimibe tablets (I) (SUVREZA®, 10 mg/10 mg) certified by Sanofi-Aventis France and produced by Sanofi Winthrop Industrie-Tours was used as the reference preparation to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations and evaluate the bioequivalence of the two preparations in humans.
Secondary objective: To observe the safety of the test preparation and the reference preparation after single fasting and postprandial oral administration in healthy subjects.
100 Clinical Results associated with Mu Yuan （ An Hui ） Yao Ye You Xian Gong Si
0 Patents (Medical) associated with Mu Yuan （ An Hui ） Yao Ye You Xian Gong Si
100 Deals associated with Mu Yuan （ An Hui ） Yao Ye You Xian Gong Si
100 Translational Medicine associated with Mu Yuan （ An Hui ） Yao Ye You Xian Gong Si
