Pillai G K, Salem M S, Najib N M, Jilani J, Hasan M M, Ghanem E, Sallam E, Shubair M S, al-Delq S
Faculty of Pharmacy, Jordan University of Science and Technology, Irbid-Jordan.
Acta Pharm Hung. 1996 Nov;66(6):231-5.
Bioequivalency of Omeraz, a test-product of Arab Pharmaceutical Manufacturing Company (Jordan) and Losec, a reference product by Astra (Sweden), was evaluated by a randomised crossover study on 22 healthy male volunteers. Serum concentrations of omeprazole were measured by an HPLC assay. There were no statistically significant differences between the two products in terms of serum profile and pharmacokinetic parameters including AUC, Cmax, Tlag, Tmax, MRT, Ke and T1/2. The AUC ratios (Omeraz/Losec) for 24 hours and for infinity were respectively 1.02 with a 90% C.L. of 0.88-1.16 and 1.00 with a 90% C.L. of 0.88-1.14. The two products may be considered as bioequivalent in terms of the extent of absorption as indicated by the AUC ratios. However, the confidence limits of Cmax fall outside the FDA accepted range.
对22名健康男性志愿者进行随机交叉研究，评估了阿拉伯制药制造公司（约旦）的试验产品奥美拉唑（Omeraz）与阿斯利康公司（瑞典）的参比产品洛赛克（Losec）的生物等效性。采用高效液相色谱法测定奥美拉唑的血清浓度。在血清曲线以及包括AUC、Cmax、Tlag、Tmax、MRT、Ke和T1/2在内的药代动力学参数方面，两种产品之间无统计学显著差异。24小时和无穷大时的AUC比值（奥美拉唑/洛赛克）分别为1.02，90%置信区间为0.88 - 1.16；以及1.00，90%置信区间为0.88 - 1.14。根据AUC比值所示的吸收程度，两种产品可被视为生物等效。然而，Cmax的置信区间超出了美国食品药品监督管理局认可的范围。
