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首页> 外文期刊>Alimentary pharmacology & therapeutics. >An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers.
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An open-label, parallel, multiple-dose study comparing the pharmacokinetics and gastric acid suppression of rabeprazole extended-release with esomeprazole 40 mg and rabeprazole delayed-release 20 mg in healthy volunteers.

机译：一项开放标签，平行，多剂量研究，比较了健康志愿者中雷贝拉唑缓释与埃索美拉唑40 mg和雷贝拉唑缓释20 mg的药代动力学和胃酸抑制作用。

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BACKGROUND: Novel rabeprazole extended-release (ER) formulations were developed to provide prolonged gastric acid suppression and potentially improved clinical outcomes in GERD patients. AIM: To evaluate the pharmacodynamics and pharmacokinetics of six rabeprazole-ER formulations vs. esomeprazole 40 mg and rabeprazole delayed-release (DR) 20 mg. METHODS: Helicobacter pylori-negative healthy subjects were randomised to receive one of eight treatments once daily for 5 days. Twenty-four-hour intragastric pH was monitored on days -1, 1 and 5. Rabeprazole plasma concentrations were measured on day 5. RESULTS: A total of 248 subjects (N=31/group) were enrolled in the study. On day 5, rabeprazole-ER groups provided mean durations of 18.5-20.2 h (77.0-84.1% of 24-h) with intragastric pH >4.0 vs. esomeprazole 40 mg (15.9 h/66.1% of 24-h) and rabeprazole-DR 20 mg (15.2 h/63.2% of 24-h). A similar increase was observed on day 1. While percentage of daytime (8 am-10 pm) with intragastric pH >4.0 on day 5 was overall similar across the groups, percentage of night-time (10 pm-8 am) with intragastric pH >4.0 was higher with the rabeprazole-ER groups (57.0-72.4%) vs. esomeprazole 40 mg (32.8%) and rabeprazole-DR 20 mg (34.0%). CONCLUSION: Rabeprazole-ER once daily for 5 days demonstrated a significantly longer duration of gastric acid suppression in 24 h vs. esomeprazole 40 mg and rabeprazole-DR 20 mg. The increase in acid suppression was predominantly due to prolonged acid suppression during the night-time; this was supported by the extended-release pharmacokinetic characteristics.
机译：背景：开发了新型雷贝拉唑缓释（ER）制剂，可延长GERD患者的胃酸抑制时间，并可能改善其临床结局。目的：评估六种雷贝拉唑-ER制剂与40毫克埃索美拉唑和20毫克雷贝拉唑缓释（DR）的药效学和药代动力学。方法：将幽门螺杆菌阴性的健康受试者随机分配，每天接受八种治疗之一，为期5天。在-1、1和5天监测24小时的胃内pH。在第5天测量雷贝拉唑的血浆浓度。结果：研究共纳入248名受试者（N = 31 /组）。在第5天，雷贝拉唑-ER组的平均持续时间为18.5-20.2小时（24小时的77.0-84.1％），其中胃内pH> 4.0，而埃索美拉唑40 mg（15.9小时/66.1%的24小时）和雷贝拉唑- DR 20毫克（24小时的15.2小时/63.2%）。在第1天观察到类似的增加。虽然各组的胃内pH值> 4.0的白天时间百分比（上午8点至晚上10点）在各组中总体相似，而胃内pH值的夜间时间百分比（下午10点至上午8点）雷贝拉唑-ER组的> 4.0更高（57.0-72.4％），而埃索美拉唑40 mg（32.8％）和雷贝拉唑-DR 20 mg（34.0％）更高。结论：雷贝拉唑-ER每天一次，连续5天，显示24小时胃酸抑制作用的持续时间明显长于40毫克埃索美拉唑和20毫克雷贝拉唑-DR。抑酸作用的增加主要是由于夜间长时间的抑酸作用。延长释放的药代动力学特征支持了这一点。

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