Wagener H H, Vögtle-Junkert U
Dolorgiet Arzneimittel, St. Augustin, Germany.
Int J Clin Pharmacol Ther. 1996 Jan;34(1):21-31.
Based upon the results of a bioequivalence study in 18 male and female healthy volunteers receiving each ibuprofen 400 mg at a time interval of 3 days the issue of the intrasubject variation is discussed. It was shown that there was bioequivalence as to the parameters Cmax, AUC0-tlast und AUC0-infinity in the volunteers who repeatedly received the same preparation. The same is true for the secondary target parameters tmax und t1/2. In the present study the intrasubject variability was determined to be 10%. Since ibuprofen does not belong to the drugs with problematic bioavailability it can be expected that in case of repeated application at an interval limited in time equal results are achieved with considerable intra-and intersubject variations.
基于一项生物等效性研究的结果，该研究对18名男性和女性健康志愿者进行，他们每次服用400毫克布洛芬，间隔3天，讨论了个体内变异的问题。结果表明，在反复接受相同制剂的志愿者中，Cmax、AUC0 - tlast和AUC0 - infinity参数具有生物等效性。次要目标参数tmax和t1/2也是如此。在本研究中，个体内变异性被确定为10%。由于布洛芬不属于生物利用度有问题的药物，可以预期，在有限时间间隔内重复给药的情况下，尽管个体内和个体间存在相当大的变异，仍能获得相同的结果。
