Sostek Mark B, Chen Yusong, Andersson Tommy
AstraZeneca LP, Wilmington, DE, USA.
Br J Clin Pharmacol. 2007 Sep;64(3):386-90. doi: 10.1111/j.1365-2125.2007.02889.x. Epub 2007 Apr 10.
To investigate the pharmacokinetics of esomeprazole before a high-fat meal vs. fasting.
This open-label, randomized, crossover study consisted of two 5-day dosing periods of esomeprazole 40 mg per day. On days 1 and 5, subjects received esomeprazole 15 min before a high-fat meal (fed) or 4 h before a non-high-fat meal (fasting).
On days 1 and 5, ratio of fed to fasting area under the plasma concentration-time curve [0.56, 90% confidence interval (CI) 0.50, 0.64, and 0.78, 90% CI 0.74, 0.82, respectively] and peak plasma concentration (0.34, 90% CI 0.28, 0.41, and 0.47, 90% CI 0.41, 0.52, respectively) were outside of the limits of bioequivalence.
Esomeprazole bioavailability was reduced when taken within 15 min before eating a high-fat meal vs. that while fasting.
研究高脂餐前与空腹时埃索美拉唑的药代动力学。
本开放标签、随机、交叉研究包括两个为期5天的给药期，每天服用40毫克埃索美拉唑。在第1天和第5天，受试者在高脂餐前15分钟（进食状态）或非高脂餐前4小时（空腹状态）服用埃索美拉唑。
在第1天和第5天，血浆浓度-时间曲线下进食状态与空腹状态的面积比[分别为0.56，90%置信区间（CI）0.50，0.64；以及0.78，90%CI 0.74，0.82]和血浆峰浓度[分别为0.34，90%CI 0.28，0.41；以及0.47，90%CI 0.41，0.52]均超出生物等效性限度。
与空腹时相比，在高脂餐前15分钟内服用埃索美拉唑时，其生物利用度降低。
