Rojanasthien Noppamas, Boonchaliew Chayanontchaimongkol, Kumsorn Boonyium, Sangdee Chaichan
Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
J Med Assoc Thai. 2003 Nov;86(11):1063-72.
The bioequivalence of 250-mg cefuroxime axetil was evaluated; Furoxime (by the Siam Bheasach Company, Thailand) as the test and Zinnat (GlaxoWellcome) as the reference. The two products were administered as a single dose according to a two-way crossover design, 1-week washout period to 12 healthy Thai male volunteers. Thereafter, serial blood samples were collected over a period of 15 hours. Plasma cefuroxime concentrations were measured by HPLC. The pharmacokinetic parameters were analyzed by noncompartmental analysis.
The Tmax [median (range, h)] of Furoxime and Zinnat were 1.5 (1.0-3.0) and 1.75 (1.0-3.5), respectively. The Tmax of Furoxime was faster than Zinnat with the mean (90% CI) of difference in Tmax of -0.5 [(-1.01)-0.01] h. Bioequivalence analysis showed that the AUC(0-infinity) and the Cmax of the two products were not significantly different. The point estimator (90% CI) for the ratio [Furoxime/Zinnat] of log transformed data of the AUC(0-infinity) and Cmax were 1.03 (0.98-1.20) and 1.09 (1.02-1.24), respectively and were within the bioequivalence range of 0.80-1.25.
评估了250毫克头孢呋辛酯的生物等效性；以泰国暹罗贝斯萨克公司生产的Furoxime作为受试制剂，葛兰素威康公司生产的Zinnat作为参比制剂。按照两周期交叉设计，给12名健康的泰国男性志愿者单剂量服用这两种产品，洗脱期为1周。此后，在15小时内连续采集血样。采用高效液相色谱法测定血浆中头孢呋辛的浓度。通过非房室分析法分析药代动力学参数。
Furoxime和Zinnat的Tmax[中位数（范围，小时）]分别为1.5（1.0 - 3.0）和1.75（1.0 - 3.5）。Furoxime的Tmax比Zinnat快，Tmax差异的均值（90%置信区间）为 - 0.5[（-1.01）- 0.01]小时。生物等效性分析表明，两种产品的AUC(0 - ∞)和Cmax无显著差异。AUC(0 - ∞)和Cmax对数转换数据的比值[Furoxime/Zinnat]的点估计值（90%置信区间）分别为1.03（0.98 - 1.20）和1.09（1.02 - 1.24），均在生物等效性范围0.80 - 1.25内。
