[Translation] Single-center, randomized, open-label, single-dose, two-dose, two-period, two-sequence crossover design of fluvoxamine maleate tablets in humans under fasting and fed administration bioequivalence studies
本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的马来酸氟伏沙明片(100mg)的药代动力学特征:以Abbott Laboratories(Singapore)Private Limited持证的马来酸氟伏沙明片(兰释®,100mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞.,评价两制剂的人体生物等效性,并观察两制剂在健康受试者中的安全性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of fluvoxamine maleate tablets (100 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach and after a meal: licensed by Abbott Laboratories (Singapore) Private Limited The fluvoxamine maleate tablet (Lanshi®, 100mg) was used as a reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations were compared to evaluate the human bioequivalence of the two preparations, and To observe the safety of the two preparations in healthy subjects.