Richards J P, Gimeno M, Moreland T A, McEwen J
Drug Development (Escocia) Ltd., Ninewells Hospital and Medical School, Madrid.
Gastroenterol Hepatol. 1999 Apr;22(4):171-5.
To determine the relative bioavailability of Ulceral (study formula) with respect to Losec (reference standard formula) and establish their bioequivalence daily doses of 20 mg of omeprazole were given during 5 consecutive days to 24 healthy volunteers. No significant differences were observed in the area under the curve (AUC0-t), a parameter directly related to the inhibition of acid secretion induced by omeprazole. The confidence interval of 90% for the difference between the two formulations for AUC0-t was within the interval of acceptance (0.80-1.25). The confidence interval for the difference between the two formulations for Cmax were also within the range of acceptance (0.70-1.43). In relation to the time for achieving (Cmax (tmax), the difference between the two formulations and the confidence interval of 95% for the tmax was 0.75 (-0.5-1.75) h indicating that no significant differences were observed between the two treatments. This study confirms the bioequivalence of Ulceral with the standard reference formulation as well as the tolerability of the two formulae.
为确定溃疡灵（研究配方）相对于洛赛克（参比标准配方）的相对生物利用度，并确定它们的生物等效性，连续5天给24名健康志愿者每日服用20毫克奥美拉唑。在曲线下面积（AUC0-t）方面未观察到显著差异，该参数与奥美拉唑诱导的胃酸分泌抑制直接相关。两种制剂AUC0-t差异的90%置信区间在接受范围内（0.80-1.25）。两种制剂Cmax差异的置信区间也在接受范围内（0.70-1.43）。关于达峰时间（tmax），两种制剂之间的差异以及tmax的95%置信区间为0.75（-0.5-1.75）小时，表明两种治疗之间未观察到显著差异。本研究证实了溃疡灵与标准参比制剂的生物等效性以及两种配方的耐受性。
