[Translation] Single-center, randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial 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 Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation diacerein capsules (specification: 50mg, manufacturer: Henan Chenglou Pharmaceutical Co., Ltd.) and the reference preparation in the fasting/postprandial state. Pharmacokinetic behavior of diacerein capsules (specification: 50mg, licensee: TRB Pharma S.A., trade name: Ambridin®) in healthy subjects to evaluate the bioequivalence of the two preparations.