[Translation] Bioequivalence Study of Isosorbide Mononitrate Sustained-release Tablets in Human
本试验旨在研究单次空腹和餐后口服南京华兴医药科技有限公司研制、湖北荆江源制药股份有限公司生产的单硝酸异山梨酯缓释片(40 mg)的药代动力学特征;以Riemser Pharma GmbH持证、Kern Pharma,SL生产的单硝酸异山梨酯缓释片(Ismo®,40 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] The purpose of this experiment is to study the pharmacokinetic characteristics of isosorbide mononitrate sustained-release tablets (40 mg) developed by Nanjing Huaxing Pharmaceutical Technology Co., Ltd. and produced by Hubei Jingjiangyuan Pharmaceutical Co., Ltd. after a single oral administration; Isosorbide Mononitrate Sustained-release Tablets (Ismo®, 40 mg) produced by Pharma GmbH licensed and produced by Kern Pharma, SL was used as the reference preparation. Human bioequivalence of preparations.
[Translation] Study on Bioequivalence of Ibuprofen Sustained-release Capsules in Human
本试验旨在研究单次空腹和餐后口服南京华兴医药科技有限公司研制、湖北荆江源制药股份有限公司生产的布洛芬缓释胶囊〔0.3 g〕的药代动力学特征;以中美天津史克制药有限公司生产的布洛芬缓释胶囊(芬必得®,0.3 g〕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,并观察两制剂在健康受试者中的安全性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of ibuprofen sustained-release capsules [0.3 g] developed by Nanjing Huaxing Pharmaceutical Technology Co., Ltd. and produced by Hubei Jingjiangyuan Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach and after a meal; Ibuprofen Sustained-release Capsules (Fenbide®, 0.3 g) produced by Smith Keline Pharmaceuticals Co., Ltd. was used as a reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the biological and biological properties of the two preparations were evaluated. efficacy, and to observe the safety of the two preparations in healthy subjects.
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