Borin M T, Forbes K K
Upjohn Laboratories, Upjohn Company, Kalamazoo, Michigan 49007.
Antimicrob Agents Chemother. 1995 Jan;39(1):273-5. doi: 10.1128/AAC.39.1.273.
The effect of a high-fat meal on absorption of a 200-mg dose of cefpodoxime proxetil oral suspension was evaluated in 20 healthy, male volunteers in a randomized, two-way crossover study. The concentrations of cefpodoxime in plasma and in urine were determined by sensitive and specific high-performance liquid chromatography methods. The area under the plasma drug concentration-time curve, time to peak concentration, and urinary excretion of cefpodoxime were significantly greater (P < or = 0.05) after administration of cefpodoxime proxetil oral suspension with food than under fasting conditions. However, the difference in the areas under the curve between fed and fasted treatments was only 11%, and application of the two one-sided tests procedure showed bioequivalence between treatments for this parameter. The slight increase in the extent of drug absorption and the slower rate of absorption which results when cefpodoxime proxetil is given with food are unlikely to be of clinical importance.
在一项随机、双向交叉研究中,对20名健康男性志愿者评估了高脂餐对200毫克剂量头孢泊肟酯口服混悬液吸收的影响。采用灵敏且特异的高效液相色谱法测定血浆和尿液中头孢泊肟的浓度。与空腹条件相比,进食时服用头孢泊肟酯口服混悬液后,血浆药物浓度-时间曲线下面积、达峰时间和头孢泊肟的尿排泄量均显著更高(P≤0.05)。然而,进食和空腹治疗的曲线下面积差异仅为11%,并且应用双向单侧检验程序表明该参数在两种治疗之间具有生物等效性。进食时服用头孢泊肟酯导致药物吸收程度略有增加且吸收速率减慢,这在临床上不太可能具有重要意义。