[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of diacerein capsules in healthy subjects
1以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂双醋瑞因胶囊(规格:50mg,生产厂家:河南程楼制药有限公司)与参比制剂双醋瑞因胶囊(规格:50mg,持证商:TRB Pharma S.A.,商品名:安必丁®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
[Translation] 1 The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behaviors of the test preparation Diacerein Capsules (Specification: 50 mg, Manufacturer: Henan Chenglou Pharmaceutical Co., Ltd.) and the reference preparation Diacerein Capsules (Specification: 50 mg, Licensee: TRB Pharma S.A., Trade Name: Ambide®) in healthy subjects after oral administration in fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.