[Translation] A fasting, single-dose, randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of dexamethasone palmitate injection in healthy subjects.
考察中国健康受试者在空腹条件下单剂量静脉注射江苏迪赛诺制药有限公司生产,汇禹远和(海南)药业有限公司持有的地塞米松棕榈酸酯注射液(规格:1ml:4mg(以地塞米松棕榈酸酯计))与由Mitsubishi Tanabe Pharma Korea Co., Ltd.生产,Mitsubishi Tanabe Pharma Corporation持有的地塞米松棕榈酸酯注射液(规格:1ml:4mg(以地塞米松棕榈酸酯计))后的体内药代动力学特征,评价两制剂的生物等效性。
[Translation] The in vivo pharmacokinetic characteristics of dexamethasone palmitate injection (Specification: 1 ml: 4 mg (as dexamethasone palmitate)) produced by Jiangsu Desano Pharmaceutical Co., Ltd. and owned by Huiyuyuanhe (Hainan) Pharmaceutical Co., Ltd. and dexamethasone palmitate injection (Specification: 1 ml: 4 mg (as dexamethasone palmitate)) produced by Mitsubishi Tanabe Pharma Korea Co., Ltd. and owned by Mitsubishi Tanabe Pharma Corporation were investigated in healthy Chinese subjects under fasting conditions, and the bioequivalence of the two preparations was evaluated.