[Translation] Randomized, open-label, single-dose, two-sequence, four-cycle, fully replicated crossover bioequivalence trial of Dobaserazide Tablets (0.25g) in Chinese healthy subjects under fasting and postprandial administration conditions
按有关生物等效性试验的规定,选择上海罗氏制药有限公司为持证商的多巴丝肼片(商品名:美多芭®;规格:左旋多巴200mg与苄丝肼50mg(相当于盐酸苄丝肼57mg))为参比制剂,对合肥英太制药有限公司生产并提供的受试制剂多巴丝肼片(规格:左旋多巴200mg与苄丝肼50mg(相当于盐酸苄丝肼57mg))进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
[Translation] According to the regulations on bioequivalence testing, Shanghai Roche Pharmaceutical Co., Ltd. was selected as the licensee of dopaserazide tablets (trade name: Madopar®; specifications: levodopa 200mg and benserazide 50mg (equivalent to hydrochloric acid benserazide 57mg)) is the reference preparation, and the test preparation dopaserazide tablets (specifications: levodopa 200mg and benserazide 50mg (equivalent to benserazide hydrochloride 57mg) produced and provided by Hefei Yingtai Pharmaceutical Co., Ltd. )) Carry out fasting and postprandial administration human bioequivalence tests, compare the absorption speed and degree of absorption of the drug in the test preparation and the reference preparation to see if the difference is within the acceptable range, and evaluate the fasting and meal administration of the two preparations. Bioequivalence under post-dose conditions.