Chun A H, Shi H H, Achari R, Dennis S, Cavanaugh J H
Pharmaceutical Products Division, Abbott Laboratories, Abbott Park, Illinois, USA.
Clin Ther. 1996 Sep-Oct;18(5):833-42. doi: 10.1016/s0149-2918(96)80043-9.
A single-dose, open-label, randomized, crossover bioavailability study was conducted in 24 healthy adult male volunteers to assess an alternative method of administration of lansoprazole capsules. The results of 22 subjects were analyzed. Subjects received regimen A (granules from a 30-mg capsule mixed with apple juice and administered through a nasogastric tube) or regimen B (an intact 30-mg capsule) during the first study period. The regimens were reversed during the second period 1 week later. Blood samples were obtained over 12 hours and pharmacokinetic variables were determined. No statistically significant differences in mean time elapsed to peak concentration, mean peak concentration, area under the curve (AUC)0-t, and AUC0-infinity were detected between regimens by using analysis of variance. Bioavailability was assessed by the 90% confidence interval of the two one-sided tests on the natural logarithm of AUC. The 90% confidence interval for the AUCzero-infinity ratio was 0.955 to 1.140 for regimens A to B. These results indicate similar bioavailabilities between the two regimens and demonstrate that lansoprazole capsules may be administered by mixing the capsule contents with apple juice for administration through a nasogastric tube.
在24名健康成年男性志愿者中进行了一项单剂量、开放标签、随机交叉生物利用度研究,以评估兰索拉唑胶囊的另一种给药方法。分析了22名受试者的结果。在第一个研究阶段,受试者接受方案A(将30毫克胶囊中的颗粒与苹果汁混合,通过鼻胃管给药)或方案B(完整的30毫克胶囊)。1周后的第二个阶段,两种方案进行了互换。在12小时内采集血样并测定药代动力学变量。通过方差分析,未检测到两种方案在达到峰值浓度的平均时间、平均峰值浓度、曲线下面积(AUC)0-t和AUC0-无穷大方面存在统计学显著差异。通过对AUC自然对数的两个单侧检验的90%置信区间评估生物利用度。方案A与方案B的AUC零至无穷大比值的90%置信区间为0.955至1.140。这些结果表明两种方案的生物利用度相似,并证明兰索拉唑胶囊可通过将胶囊内容物与苹果汁混合后经鼻胃管给药。