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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >A single-dose, open-label, parallel, randomized, dose-proportionality study of paliperidone after intramuscular injections of paliperidone palmitate in the deltoid or gluteal muscle in patients with schizophrenia
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A single-dose, open-label, parallel, randomized, dose-proportionality study of paliperidone after intramuscular injections of paliperidone palmitate in the deltoid or gluteal muscle in patients with schizophrenia

机译：对精神分裂症患者的三角肌或臀肌肌肉内注射帕潘立酮棕榈酸酯后，对帕潘立酮进行单剂量，开放标签，平行，随机，剂量比例研究

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摘要

Paliperidone palmitate (PP) is a long-acting injectable (LAI) antipsychotic, developed for monthly intramuscular (i.m.) administration into deltoid/gluteal muscle, approved for the treatment of schizophrenia in many countries. To assess the options for i.m. injection sites, dose-proportionality of PP was investigated after injection of a single dose (25-150mgeq.) of PP in either gluteal (n=106) or deltoid (n=95) muscle of schizophrenic patients. Overall, mean (geometric) area under plasma concentration-time curve from time zero to infinity (AUC∞) of paliperidone increased proportionally with increasing PP doses, regardless of injection site. Mean maximum plasma concentration (Cmax) was slightly less than dose-proportional for both injection sites at PP doses 50mgeq. Mean C max was higher after injection in the deltoid compared with the gluteal muscle, except for the 100mgeq. dose, while AUC∞ for both injection sites was comparable at all doses. Median time to reach C max (tmax) ranged from 13-14 days after deltoid and 13-17 days after gluteal injection across all doses. Single PP injections in deltoid and gluteal muscles in the dose range of 25-150mgeq. were generally tolerable both locally and systemically.
机译：帕潘立酮棕榈酸酯（PP）是一种长效可注射（LAI）抗精神病药，开发用于每月对三角肌/臀肌进行肌肉内（i.m.）给药，已在许多国家被批准用于治疗精神分裂症。评估i.m.的选项注射部位，在精神分裂症患者的臀肌（n = 106）或三角肌（n = 95）注射单剂量（25-150mgeq。）PP后，研究PP的剂量比例性。总体而言，帕潘立酮的血浆浓度-时间曲线下从零时到无限远（AUC∞）的平均（几何）面积与PP剂量的增加成比例地增加，而与注射部位无关。当PP剂量> 50mgeq时，两个注射部位的平均最大血浆浓度（Cmax）略小于剂量比例。除100mgeq外，注射三角肌后的平均C max高于臀肌。剂量，而两个注射部位的AUC∞在所有剂量下均相当。在所有剂量下，达到三角肌最大时间（tmax）的中位时间为三角肌注射后13-14天和臀肌注射后13-17天。在三角肌和臀肌中单次PP注射的剂量范围为25-150mgeq。在本地和系统上都可以容忍。

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