[Translation] Human bioequivalence test of topiramate tablets under fasting and postprandial 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] Main research purpose: To investigate the single oral administration of Topiralast tablets (tested preparation, specification: 60 mg) provided by Senmiao (Shandong) Pharmaceutical Co., Ltd. under fasting or postprandial conditions or a single oral administration under the same conditions by the Co., Ltd. The pharmacokinetic characteristics of topiralast tablets (reference preparation, trade name: TOPILORIC®, specification: 60 mg) produced by Fuji Herbal Medicine, evaluate the bioequivalence between the two preparations, and provide the basis for the registration application of the test preparation.
Secondary research objectives: To observe the effects of a single oral dose of test preparation Topiralast Tablets (strength: 60mg) or reference preparation Topiralast Tablets (strength: 60mg) in healthy Chinese subjects under fasting and postprandial conditions. safety.
[Translation] Human bioequivalence test of topiramate tablets under fasting and postprandial 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] Main research purpose: To investigate the single oral administration of Topiralast tablets (tested preparation, specification: 60 mg) provided by Senmiao (Shandong) Pharmaceutical Co., Ltd. under fasting or postprandial conditions or a single oral administration under the same conditions by the Co., Ltd. The pharmacokinetic characteristics of topiralast tablets (reference preparation, trade name: TOPILORIC®, specification: 60 mg) produced by Fuji Herbal Medicine, evaluate the bioequivalence between the two preparations, and provide the basis for the registration application of the test preparation. Secondary research objectives: To observe the effects of a single oral dose of test preparation Topiralast Tablets (strength: 60mg) or reference preparation Topiralast Tablets (strength: 60mg) in healthy Chinese subjects under fasting and postprandial conditions. safety.
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] Human bioequivalence test after oral administration of betahistine hydrochloride tablets in healthy subjects on an empty stomach and after meals
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] Main purpose: Take betahistine hydrochloride tablets (specification: 8mg) produced by Jinan Yongning Pharmaceutical Co., Ltd. and held by Senmiao (Shandong) Pharmaceutical Co., Ltd. as the test preparation, produced by Mylan Laboratories SAS, Mylan Medical SAS The betahistine hydrochloride tablet (trade name: Serc, specification: 8mg) sold by the company is the reference preparation, and the human bioequivalence test in fasting/postprandial state is carried out to evaluate the bioequivalence of the test preparation and the reference preparation sex. Secondary objective: To observe the safety of test preparation and reference preparation in healthy subjects in fasting/postprandial state.
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