[Translation] Dopaserazide Tablets developed by Wuhan Renfu Pharmaceutical Co., Ltd. and Dopaserazide Tablets (trade name: Madopar ® ), whose licensee is Shanghai Roche Pharmaceutical Co., Ltd., were randomized among Chinese healthy subjects. , open, single-dose, two-sequence, four-period, crossover, fasting and postprandial bioequivalence studies
以武汉人福药业有限责任公司研制的多巴丝肼片(规格:0.25 g)为受试制剂,以上海罗氏制药有限公司生产的多巴丝肼片(商品名:美多芭®,规格:0.25 g)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Dopaserazide tablets (specification: 0.25 g) developed by Wuhan Renfu Pharmaceutical Co., Ltd. were used as the test preparation, and Dopaserazide tablets (trade name: Madopar®, : 0.25 g) as the reference preparation, investigate the pharmacokinetic parameters and relative bioavailability of the two preparations in a single administration under fasting and postprandial states, and evaluate whether the two preparations have bioequivalence; evaluate the two preparations at the same time Safety and Tolerability in Healthy Humans.