[Translation] Bioequivalence study of topirastat tablets in humans under fasting and fed conditions
主要研究目的：考察空腹或餐后条件下单次口服由森淼（山东）药业有限公司提供的托吡司特片（受试制剂，规格：60mg）或相同条件下单次口服由株式会社富士薬品生产的托吡司特片（参比制剂，商品名：TOPILORIC®，规格：60mg）的药动学特征，评价两制剂间的生物等效性，为受试制剂的注册申请提供依据。
次要研究目的：观察空腹及餐后条件下单次口服受试制剂托吡司特片（规格：60mg）或参比制剂托吡司特片（规格：60mg）在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of topirastat tablets (test preparation, specification: 60 mg) provided by Senmiao (Shandong) Pharmaceutical Co., Ltd. or topirastat tablets (reference preparation, trade name: TOPILORIC®, specification: 60 mg) produced by Fuji Pharmaceutical Co., Ltd. under the same conditions after a single oral administration under fasting or postprandial conditions, evaluate the bioequivalence between the two preparations, and provide a basis for the registration application of the test preparation.
Secondary purpose of the study is to observe the safety of the test preparation topirastat tablets (specification: 60 mg) or the reference preparation topirastat tablets (specification: 60 mg) in Chinese healthy subjects after a single oral administration under fasting and postprandial conditions.
[Translation] Bioequivalence study of topiramate tablets in humans under fasting and fed conditions
主要研究目的：考察空腹或餐后条件下单次口服由森淼（山东）药业有限公司提供的托吡司特片（受试制剂，规格：60mg）或相同条件下单次口服由株式会社富士薬品生产的托吡司特片（参比制剂，商品名：TOPILORIC®，规格：60mg）的药动学特征，评价两制剂间的生物等效性，为受试制剂的注册申请提供依据。次要研究目的：观察空腹及餐后条件下单次口服受试制剂托吡司特片（规格：60mg）或参比制剂托吡司特片（规格：60mg）在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of topirastat tablets (test preparation, strength: 60 mg) provided by Senmiao (Shandong) Pharmaceutical Co., Ltd. or topirastat tablets (reference preparation, trade name: TOPILORIC®, strength: 60 mg) produced by Fuji Pharmaceutical Co., Ltd. under the same conditions after a single oral administration under fasting or postprandial conditions, evaluate the bioequivalence between the two preparations, and provide a basis for the registration application of the test preparation. The secondary purpose of the study is to observe the safety of the test preparation topirastat tablets (strength: 60 mg) or the reference preparation topirastat tablets (strength: 60 mg) in Chinese healthy subjects after a single oral administration under fasting and postprandial conditions.
健康受试者空腹及餐后状态下口服盐酸倍他司汀片后人体生物等效性试验
[Translation] Bioequivalence study of oral betahistine hydrochloride tablets in healthy subjects in fasting and fed state
主要目的：以济南永宁制药股份有限公司生产，森淼（山东）药业有限公司持有的盐酸倍他司汀片（规格：8mg）为受试制剂，以Mylan Laboratories SAS 公司生产，Mylan Medical SAS 公司销售的盐酸倍他司汀片（商品名：Serc，规格：8mg）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂与参比制剂的生物等效性。次要目的：观察空腹/餐后状态下，受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To conduct a human bioequivalence study in the fasting/fed state using Betahistine Hydrochloride Tablets (Specification: 8 mg) produced by Jinan Yongning Pharmaceutical Co., Ltd. and owned by Senmiao (Shandong) Pharmaceutical Co., Ltd. as the test preparation and Betahistine Hydrochloride Tablets (Trade Name: Serc, Specification: 8 mg) produced by Mylan Laboratories SAS and sold by Mylan Medical SAS as the reference preparation, and to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects in the fasting/fed state.
100 Clinical Results associated with Senmiao (Shandong) Pharmaceutical Co., Ltd.
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100 Deals associated with Senmiao (Shandong) Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Senmiao (Shandong) Pharmaceutical Co., Ltd.
