[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of duloxetine hydrochloride enteric-coated capsules in healthy subjects with fasting and postprandial diet
试验旨在研究单次空腹和餐后口服兰晟生物医药(苏州)有限公司研制、永信药品工业(昆山)股份有限公司生产的盐酸度洛西汀肠溶胶囊(60 mg)的药代动力学特征;以LILLY DEL CARIBE, INC. 生产的盐酸度洛西汀肠溶胶囊(Cymbalta®,60 mg)为参比制剂,比较两制剂的药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The study aimed to study the pharmacokinetic characteristics of duloxetine hydrochloride enteric-coated capsules (60 mg) developed by Lansheng Biopharmaceuticals (Suzhou) Co., Ltd. and produced by Yongxin Pharmaceutical Industry (Kunshan) Co., Ltd. after single fasting and postprandial oral administration; duloxetine hydrochloride enteric-coated capsules (Cymbalta®, 60 mg) produced by LILLY DEL CARIBE, INC. were used as the reference preparation, and the pharmacokinetic parameters of the two preparations, including Cmax, AUC0-t, and AUC0-∞, were compared to evaluate the bioequivalence of the two preparations in humans.