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目的探讨奥美拉唑肠溶片在人体生物等效性。方法20名健康男性志愿者随机分为 A、B两组，随机交叉、自身对照试验设计，每名受试者在两周期内分别单剂量口服山西同达药业有限公司研制的奥美拉唑肠溶片(受试制剂)或阿斯利康制药有限公司生产的奥美拉唑肠溶片(参比制剂)各40 mg。HPLC-UV法测定血浆中的奥美拉唑浓度，采用DAS Ver2.1软件计算药动学参数：达峰浓度(Cmax )、达峰时间(tmax )、药时曲线下面积(AUC)和半衰期(t1/2)。结果口服奥美拉唑肠溶片受试制剂和参比制剂后，其主要药动学参数如下：Cmax分别为(1.43±0.40)mg/L和(1.51±0.42)mg/L；tmax分别为(1.70±0.38)h和(1.53±0.47)h；AUC0→10分别为(3.80±2.02)mg/(h·L)和(4.06±2.10)mg/(h·L)；AUC0→∞分别为(3.90±2.14)mg/(h·L)和(4.18±2.22)mg/(h·L)；t1/2分别为(1.54±0.89)h和(1.53±0.61)h。与参比制剂相比，受试制剂的相对生物利用度为(94.7±16.5)%。结论奥美拉唑肠溶片受试制剂与参比制剂两者共有生物等效性。“,”Objective]To explore the bioequivalence of omeprazole enteric-coated capsule in human body.[Methods]A total of 20 healthy male volunteers were randomly divided into group A and group B by using random-ized crossover and own control trial method.Each subject was given single oral dose of 40mg omeprazole enteric-coa-ted tablets(tested formulation)produced by Shanxi Tongda pharmaceutical limited company or 40mg omeprazole en-teric-coated tablets (reference formulation)produced by AstraZeneca pharmaceutical limited company,respectively. HPLC-UV method was used to measure plasma concentrations of omeprazole.The pharmacokinetics parameters such as the maximum concentration (Cmax ),the peak time(tmax ),area under curve(AUC)and half life(t1/2 )were calculat-ed by DAS Ver2 .1 program.[Results]After oral omeprazole enteric-coated tablets,the main pharmacokinetics param-eters of tested formulation and reference formulation were as follows:Cmax were (1.43±0.395)mg/L and (1.51±0. 42)mg/L,tmax were (1.70±0.38)h and (1.53±0.47)h,AUC0 10 were (3.80±2.02)mg/(h·L)and (4.06±2. 10)mg/(h·L),AUC0 ∞ were (3.90±2.14)mg/(h·L)and (4.18±2.22)mg/(h·L),t1/2 were (1.54±0.89)h and (1.53±0.61)h.Compared with the reference formulation,the relative bioavailability of the tested formulation was (94.7±16.5)%.[Conclusion]The reference and test formulations of omeprazole enteric-coated tablets have bioequivalence.