[Translation] Randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of fluvoxamine maleate tablets (50 mg) under fasting and fed administration conditions in Chinese healthy subjects
主要研究目的:按有关生物等效性试验的规定,选择Abbott Laboratories (Singapore) Private Limited为持证商的马来酸氟伏沙明片(商品名:Luvox®,规格:50mg)为参比制剂,对湖南省湘中制药有限公司生产的受试制剂马来酸氟伏沙明片(规格:50mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂马来酸氟伏沙明片(规格:50mg)和参比制剂马来酸氟伏沙明片(商品名:Luvox®,规格:50mg)的安全性。
[Translation] The main purpose of the study: to select fluvoxamine maleate tablets (trade name: Luvox®, specification: 50mg) with Abbott Laboratories (Singapore) Private Limited as the licensee, as the reference preparation according to the relevant bioequivalence test regulations , the test preparation fluvoxamine maleate tablet (specification: 50mg) produced by Hunan Xiangzhong Pharmaceutical Co., Ltd. was administered to humans on an empty stomach and after meals for bioequivalence tests, and the absorption rate of the drug in the test preparation was compared Whether the difference between the absorption degree and the reference preparation is within an acceptable range, and evaluate the bioequivalence of the two preparations under fasting and fed administration conditions.
Secondary research purpose: To observe the oral administration of the test preparation fluvoxamine maleate tablet (specification: 50mg) and the reference preparation fluvoxamine maleate tablet (trade name: Luvox®, specification: 50mg) in healthy volunteers. ) for security.