[Translation] Bioequivalence study of fluvoxamine maleate tablets in healthy subjects under randomized, open, single-dose, two-dose, two-sequence, two-period crossover fasting/fed states
主要目的:健康受试者空腹/餐后状态下,口服单剂量马来酸氟伏沙明片(受试制剂T,沈阳福宁药业有限公司生产,规格:50mg/片)与马来酸氟伏沙明片(参比制剂R,Abbott Laboratories (Singapore) Private Limited持证,Mylan Laboratories SAS生产,商品名:Luvox®/兰释®,规格:50mg/片)后,考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂马来酸氟伏沙明片和参比制剂马来酸氟伏沙明片(Luvox®/兰释®)在健康受试者中的安全性。
[Translation] Main purpose: Under fasting/after meal conditions, healthy subjects were orally administered a single dose of fluvoxamine maleate tablets (test preparation T, produced by Shenyang Funing Pharmaceutical Co., Ltd., specification: 50mg/tablet) combined with maleic acid After fluvoxamine tablets (reference preparation R, licensed by Abbott Laboratories (Singapore) Private Limited, produced by Mylan Laboratories SAS, trade name: Luvox®/Blue Release®, specification: 50mg/tablet), the fasting and postprandial conditions were investigated Under the absorption speed and degree of absorption of the test preparation and the reference preparation, evaluate whether the test preparation and the reference preparation have bioequivalence.
Secondary purpose: To observe the safety of the test preparation fluvoxamine maleate tablets and the reference preparation fluvoxamine maleate tablets (Luvox®/Lanshi®) in healthy subjects.