[Translation] A single-center, randomized, open-label, two-formulation, two-period, two-sequence, single-dose, crossover design bioequivalence study of mianserin hydrochloride tablets in Chinese healthy participants under fasting and postprandial conditions.
主要目的:以米安色林的主要药代动力学参数(AUC和Cmax)为生物等效性评价指标,在中国健康试验参与者空腹和餐后状态下评估受试制剂(成都明德至远医药科技有限公司申报的盐酸米安色林片,规格:30mg)和参比制剂(MSD K.K.持证的盐酸米安色林片,规格:30mg;商品名:Tetramide®)的生物等效性。
次要目的:观察空腹和餐后状态下受试制剂和参比制剂的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test formulation (mianserin hydrochloride tablets, 30 mg, developed by Chengdu Mingde Zhiyuan Pharmaceutical Technology Co., Ltd.) and the reference formulation (mianserin hydrochloride tablets, 30 mg, certified by MSD K.K.; trade name: Tetramide®) in fasting and postprandial subjects in healthy Chinese trial participants, using the primary pharmacokinetic parameters (AUC and Cmax) as bioequivalence indicators.
Secondary objective: To observe the safety of the test and reference formulations in fasting and postprandial states.