[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of dopamine tablets (0.25 g) in Chinese healthy subjects under fasting 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给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, Dopamine Tablets (trade name: Madopar®; specifications: 200 mg levodopa and 50 mg benserazide (equivalent to 57 mg benserazide hydrochloride)) produced by Shanghai Roche Pharmaceuticals Co., Ltd. as the certified manufacturer were selected as the reference preparation, and the test preparation Dopamine Tablets (specifications: 200 mg levodopa and 50 mg benserazide (equivalent to 57 mg benserazide hydrochloride)) produced and provided by Hefei Yingtai Pharmaceutical Co., Ltd. were subjected to a human bioequivalence test on fasting administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting administration conditions was evaluated.