[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.