茶苯海明片在健康受试者中单中心、随机、开放、单次给药、四周期、完全重复交叉的空腹及餐后状态下生物等效性试验
[Translation] A single-center, randomized, open-label, single-dose, four-cycle, fully repeated crossover bioequivalence study of dimenhydrinate tablets in healthy subjects in fasting and postprandial states
主要目的:以江苏黄河药业股份有限公司生产的茶苯海明片(商品名:宁新宝®)为受试制剂,按生物等效性试验的有关规定,与株式会社陽進堂生产的持证商为Yoshindo Inc.的茶苯海明片(商品名:Dramamine®)为参比制剂,对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
次要目的:观察受试制剂茶苯海明片(商品名:宁新宝®)和参比制剂茶苯海明片(商品名:Dramamine ®)在健康受试者中的安全性。
[Translation] Main purpose: Take Dimenhydrinate Tablets (trade name: Ningxinbao®) produced by Jiangsu Yellow River Pharmaceutical Co., Ltd. as the test preparation, and in accordance with the relevant regulations of bioequivalence test, and the product produced by Yangjintang Co., Ltd. Dimenhydrinate Tablets (trade name: Dramamine®), whose licensee is Yoshindo Inc., was used as the reference preparation to compare the absorption rate and degree of absorption in healthy humans, and to investigate the human bioequivalence of the two preparations.
Secondary objective: To observe the safety of the test preparation Dimenhydrinate Tablets (trade name: Ningxinbao®) and the reference preparation Dimenhydrinate Tablets (trade name: Dramamine ®) in healthy subjects.
在健康受试者中于餐后情况下进行的格列齐特缓释片的单剂量、随机、开放性、双周期、双交叉的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-cycle, two-crossover bioequivalence study of gliclazide extended-release tablets in healthy subjects
主要研究目的
在健康男性和女性受试者中于餐后情况下评价格列齐特缓释片和Diamicron®的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。
次要研究目的
评估受试制剂格列齐特缓释片和参比制剂Diamicron®在中国健康受试者中的安全性。
[Translation] Main research purpose
The rate and extent of absorption of Gliclazide extended-release tablets and Diamicron® were evaluated in healthy male and female subjects after meals to assess whether the two formulations were bioequivalent.
Secondary research purpose
To evaluate the safety of the test preparation Gliclazide extended-release tablets and the reference preparation Diamicron® in healthy Chinese subjects.
在健康受试者中于空腹情况下进行的格列齐特缓释片的单剂量、随机、开放性、双周期、双交叉的生物等效性研究
[Translation] A single-dose, randomized, open-label, two-cycle, two-crossover bioequivalence study of gliclazide extended-release tablets in healthy subjects
主要研究目的
在健康男性和女性受试者中于空腹情况下评价格列齐特缓释片和Diamicron®的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。
次要研究目的
评估受试制剂格列齐特缓释片和参比制剂Diamicron®在中国健康受试者中的安全性。
[Translation] Main research purpose
The rate and extent of absorption of Gliclazide extended-release tablets and Diamicron® were evaluated in healthy male and female subjects on an empty stomach to assess whether the two formulations were bioequivalent.
Secondary research purpose
To evaluate the safety of the test preparation Gliclazide extended-release tablets and the reference preparation Diamicron® in healthy Chinese subjects.
100 Clinical Results associated with Jiangsu Yellow River Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Jiangsu Yellow River Pharmaceutical Co., Ltd.