[Translation] Cilipride tartrate tablets (specification: 1 mg) developed by Zhejiang Yuanlijian Pharmaceutical Co., Ltd. and Cilipride tartrate tablets (trade name: Cidine®/Cidine®, licensed by Almirall, S.A., Strength: 1 mg) A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, double-crossover design fasting bioequivalence study in Chinese healthy subjects, as well as in Chinese Health Single-center, randomized, open-label, two-formulation, single-dose, four-cycle, two-sequence, fully replicated crossover design postprandial bioequivalence study in subjects
以浙江远力健药业有限责任公司研制的酒石酸西尼必利片(规格:1 mg)为受试制剂,以持证商为Almirall, S.A.的酒石酸西尼必利片(商品名:希笛尼®/Cidine®,规格:1 mg)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] Cilipride tartrate tablets (specification: 1 mg) developed by Zhejiang Yuanlijian Pharmaceutical Co., Ltd. were used as the test preparation. Cilipride tartrate tablets (trade name: Xidi Cidine®/Cidine®, specification: 1 mg) is a reference preparation. The pharmacokinetic parameters and relative bioavailability of a single dose of the two preparations under fasting and postprandial conditions are examined to evaluate whether the two preparations are bioequivalent. sex. The safety and tolerability of both formulations in healthy humans were also evaluated.