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首页> 外文期刊>Current therapeutic research, clinical and experimental. >Pharmacokinetic interaction between fluoxetine and omeprazole in healthy male volunteers: A prospective pilot study
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Pharmacokinetic interaction between fluoxetine and omeprazole in healthy male volunteers: A prospective pilot study

机译：氟西汀和奥美拉唑在健康男性志愿者中的药代动力学相互作用：一项前瞻性研究

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Background: Fluoxetine is an inhibitor of the main metabolizing enzymes (cytochrome P450 [CYP] 2C19 and CYP3A4) of omeprazole and thus might influence that drug's pharmacokinetics. The changes in omeprazole's pharmacokinetics may have clinical significance concerning efficacy and tolerability of the treatment. Objective: The aim of this study was to assess the pharmacokinetic interaction of fluoxetine with omeprazole in healthy volunteers. Methods: The study enrolled healthy adult men and consisted of 2 periods. In the first period, all subjects received a single 40-mg dose of omeprazole. This was followed by an 8-day period during which fluoxetine monotherapy (60 mg/d) was administered as a single oral daily dose. At the end of those 8 days, the subjects were administered a 40-mg dose of omeprazole with a 60-mg dose of fluoxetine. Plasma concentrations of omeprazole were determined at 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, and 12 hour(s) after study drug administration. Omeprazole plasma concentrations were determined by a validated HPLC method. Pharmacokinetic parameters of omep-razole were calculated using noncompartmental analysis. Adverse events were assessed throughout the study duration. Results: Eighteen healthy male volunteers (mean [SD] age, 22.11 [2.52] years [range, 18-26 years]; body mass index, 23.34 [2.31] kg/m2 [range, 19.1-27.1 kg/m2]) were enrolled and completed the study. In the 2 periods of treatment, the mean Cmax of omeprazole was 730.8 ng/mL (omeprazole monotherapy) and 1725.5 ng/mL (combination treatment with fluoxetine). The observed AUC0-? was 1453.3 and 5072.5 ng/mL/h and AUC0-t was 1465.0 and 5185.3 ng/mL/h, respectively. The Tmax was 1.30 and 1.63 hours and the elimination rate constant was 0.753 and 0.482 hr-1. The t was 0.96 and 1.47 hours, whereas the mean residence time was 2.33 and 3.35 hours, respectively. Statistically significant differences were observed for all parameters between periods 1 and 2 (all, P 0.001). Conclusion: The data found in this prospective pilot study suggest a pharmacokinetic interaction between fluoxetine and omeprazole in these healthy volunteers, but its relevance has to be confirmed.
机译：背景：氟西汀是奥美拉唑的主要代谢酶（细胞色素P450 [CYP] 2C19和CYP3A4）的抑制剂，因此可能影响该药的药代动力学。奥美拉唑药代动力学的变化可能对治疗的疗效和耐受性具有临床意义。目的：本研究旨在评估氟西汀与奥美拉唑在健康志愿者中的药代动力学相互作用。方法：该研究招募了健康成年男性，分为2个时期。在第一阶段，所有受试者均接受40毫克单剂量的奥美拉唑。随后为期8天，在此期间氟西汀单药（60 mg / d）每天口服一次。在这8天的末期，给受试者施用40mg剂量的奥美拉唑和60mg剂量的氟西汀。在研究药物给药后的0.5、1、1.33、1.66、2、2.5、3、4、5、6、7、8、10和12小时测定了奥美拉唑的血浆浓度。奥美拉唑血浆浓度通过有效的HPLC方法测定。使用非房室分析计算奥美拉唑的药代动力学参数。在整个研究过程中评估不良事件。结果：18名健康男性志愿者（平均[SD]年龄，22.11 [2.52]年[范围，18-26岁];体重指数，23.34 [2.31] kg / m2 [范围，19.1-27.1 kg / m2]）参加并完成研究。在这两个疗程中，奥美拉唑的平均Cmax为730.8 ng / mL（奥美拉唑单药治疗）和1725.5 ng / mL（与氟西汀联合治疗）。观察到的AUC0-？分别为1453.3和5072.5 ng / mL / h，AUC0-t为1465.0和5185.3 ng / mL / h。 Tmax为1.30和1.63小时，消除速率常数为0.753和0.482hr-1。 t为0.96和1.47小时，而平均停留时间分别为2.33和3.35小时。在第1到第2阶段之间，所有参数的差异均具有统计学意义（均P <0.001）。结论：这项前瞻性研究中的数据表明氟西汀和奥美拉唑在这些健康志愿者中具有药代动力学相互作用，但必须确定其相关性。

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