Thomson A B, Sinclair P, Matisko A, Rosen E, Andersson T, Olofsson B
Division of Gastroenterology, University of Alberta, Edmonton.
Can J Gastroenterol. 1997 Nov-Dec;11(8):663-7. doi: 10.1155/1997/830856.
The objective of this study was to investigate the influence of food on the bioavailability of omeprazole (20 mg) given as an enteric-coated tablet under repeated dose conditions. This open randomized crossover study consisted of three seven-day treatment periods, each separated by a drug-free period. During each treatment period an enteric-coated tablet of omeprazole was taken once daily either under fasting conditions, or immediately before or after a standardized breakfast. On the last day of each treatment period, blood samples for the determination of plasma omeprazole concentrations were collected at baseline and at predetermined intervals over the 24 h period following drug administration. Fifty-seven male and female subjects, aged 18 to 52 years, completed the study according to the protocol. No statistically significant differences were found when comparing either the before breakfast or after breakfast treatment regimens with the fasting regimen for the estimated mean area under the plasma concentration-time curve (AUC). The maximum plasma concentration was not found to differ significantly among any of the treatment regimens. However, the lower limit of the CI for the comparison of fasting/before breakfast was not contained within the limits of bioequivalence. The time to reach maximum plasma concentration was significantly different when fasting and after breakfast regimens were compared. Thus, under repeated dose conditions, food has no influence on the bioavailability (expressed as AUC) of omeprazole given as the enteric-coated tablet formulation.
本研究的目的是在重复给药条件下，研究食物对肠溶衣片形式给予的奥美拉唑（20毫克）生物利用度的影响。这项开放随机交叉研究包括三个为期七天的治疗期，每个治疗期之间有一个无药期。在每个治疗期内，奥美拉唑肠溶衣片每天服用一次，要么在禁食条件下，要么在标准早餐前或后立即服用。在每个治疗期的最后一天，在给药后的24小时内，于基线和预定时间点采集血样以测定血浆奥美拉唑浓度。57名年龄在18至52岁之间的男性和女性受试者按照方案完成了研究。在比较早餐前或早餐后治疗方案与禁食方案的血浆浓度-时间曲线下估计平均面积（AUC）时，未发现统计学上的显著差异。在任何治疗方案中，最大血浆浓度均未发现有显著差异。然而，禁食/早餐前比较的置信区间下限未包含在生物等效性范围内。比较禁食和早餐后方案时，达到最大血浆浓度的时间有显著差异。因此，在重复给药条件下，食物对肠溶衣片形式给予的奥美拉唑的生物利用度（以AUC表示）没有影响。
