[Translation] A single-dose, randomized, open-label, two-period, two-sequence, crossover bioequivalence study of diacerein capsules in healthy volunteers under fasting and fed conditions
主要研究目的:研究空腹和餐后状态下单次口服受试制剂双醋瑞因胶囊(规格:50mg,生产持证单位:葵花药业集团湖北武当有限公司)与参比制剂双醋瑞因胶囊(商品名:安必丁®ARTRODAR®,规格:50mg,生产持证单位:TRB Pharma S.A.)在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评估空腹和餐后状态口服两种制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:空腹和餐后状态下,研究单次口服双醋瑞因胶囊受试制剂和参比制剂在健康成年受试者中的安全性。
[Translation] Main research objectives: To study the relative bioavailability of the test preparation Diacerein Capsules (specification: 50 mg, licensed manufacturer: Sunflower Pharmaceutical Group Hubei Wudang Co., Ltd.) and the reference preparation Diacerein Capsules (trade name: ARTRODAR®, specification: 50 mg, licensed manufacturer: TRB Pharma S.A.) in healthy Chinese subjects after a single oral administration in the fasting and fed state, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state, and provide a reference for the application and clinical use of the drug.
Secondary research objectives: To study the safety of the test preparation and reference preparation of Diacerein Capsules in healthy adult subjects after a single oral administration in the fasting and fed state.