[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of diacerein capsules in healthy Chinese adult subjects
主要研究目的:
考察空腹/餐后单次口服受试制剂双醋瑞因胶囊(规格:50 mg,江苏永安制药有限公司生产)与参比制剂双醋瑞因胶囊(商品名:安必丁®,规格:50 mg,TRB Pharma S.A.持证),在中国成年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,评价两制剂的生物等效性。
次要研究目的:
评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of the test preparation Diacerein Capsules (specification: 50 mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) and the reference preparation Diacerein Capsules (trade name: Ambide®, specification: 50 mg, licensed by TRB Pharma S.A.) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary study objectives:
To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.