[Translation] Study plan for a randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of dopamine tablets in Chinese healthy subjects under fasting and fed conditions
主要研究目的: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,对安徽贝克生物制药有限公司生产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条件下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。
次要研究目的:观察健康志愿受试者口服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))和参比制剂多巴丝肼片(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))的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the 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. 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 by Anhui Baker Biopharmaceutical Co., Ltd. were subjected to human bioequivalence test under fasting and postprandial administration conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study objective: To observe the safety of oral administration of the test preparation dobaserazide tablets (specifications: 200 mg levodopa and 50 mg benserazide (equivalent to 57 mg benserazide hydrochloride)) and the reference preparation dobaserazide tablets (trade name: Madopa®; specifications: 200 mg levodopa and 50 mg benserazide (equivalent to 57 mg benserazide hydrochloride)) in healthy volunteers.