[Translation] Single-center, randomized, open-label, two-preparation, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial of dexamethasone acetate tablets in healthy subjects
主要目的: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醋酸地塞米松片(生产厂家:新乡市常乐制药有限责任公司)与参比制剂醋酸地塞米松片(持证商:SANOFI AVENTIS FRANCE,商品名:Dectancyl®)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。
次要目的:观察受试制剂醋酸地塞米松片和参比制剂醋酸地塞米松片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation dexamethasone acetate tablets (manufacturer: Xinxiang Changle Pharmaceutical Co., Ltd.) and the reference preparation in the fasting/postprandial state. The pharmacokinetic behavior of dexamethasone acetate tablets (licensee: SANOFI AVENTIS FRANCE, trade name: Dectancyl®) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations.
Secondary purpose: To observe the safety of the test preparation dexamethasone acetate tablets and the reference preparation dexamethasone acetate tablets in healthy subjects.