[Translation] A single-center, randomized, open-label, single-dose, four-period, completely repeated crossover bioequivalence study of dimenhydrinate tablets in healthy subjects under fasting and fed conditions
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: Taking dimenhydrinate tablets (trade name: Ningxinbao®) produced by Jiangsu Huanghe Pharmaceutical Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence testing, it will be compared with Dimenhydrinate tablets produced by Yangjindo Co., Ltd. The license holder is Yoshindo Inc.’s Dimenhydrinate Tablets (trade name: Dramamine®) as a reference preparation. The absorption speed and extent of absorption in healthy humans were compared to examine the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation Dimenhydrinate Tea Tablets (trade name: Ningxinbao®) and the reference preparation Dimenhydrinate Tea Tablets (trade name: Dramamine ®) in healthy subjects.