[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of macitentan tablets (10 mg) produced by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. and macitentan tablets (10 mg) certified by Actelion Pharmaceuticals Ltd. in healthy subjects under fasting and fed conditions
以宁波美诺华天康药业有限公司生产的马昔腾坦片(规格:10 mg)为受试制剂,Actelion Pharmaceuticals Ltd. 持证的马昔腾坦片(商品名:傲朴舒®,规格:10mg)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,评价两制剂是否具有生物等效性
[Translation] The macitentan tablets (specification: 10 mg) produced by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. were used as the test preparation, and the macitentan tablets (trade name: Apoquel®, specification: 10 mg) licensed by Actelion Pharmaceuticals Ltd. were used as the reference preparation. The pharmacokinetic parameters of the two preparations were investigated in the fasting and postprandial state after a single dose, and whether the two preparations were bioequivalent was evaluated.