老年健康志愿者单次口服20mg羟西康的药代动力学研究

J Hosie, J Kelly, J Sánchez, A Bartlett, F J Harrison
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引用次数: 0

摘要

本研究对10名健康老年志愿者进行单次口服药代动力学研究,以评估其药代动力学特征以及年龄对羟西康吸收、分布和消除的潜在影响。在完整的医学筛查和知情的书面同意后,在医学监督下给所有志愿者服用一剂(20mg) droxicam。在120小时内评估获得的血浆水平的完整药代动力学特征。所有的志愿者都完成了研究,没有一个人会产生不耐受或副作用。结果显示,羟基昔康的吸收、分布和消除与对年轻健康志愿者进行的参考研究没有实质性差异。10 h时血药浓度峰值为1.38 +/- 0.29微克/ml,下降缓慢,120 h时降至0.24 +/- 0.20微克/ml,半衰期为50.23 +/- 17.19小时,消除速率常数为0.015 +/- 0.005微克/ml.h-1。与健康的年轻志愿者相比,这种差异很小。从本研究中可以得出结论,年龄对droxicam的吸收和分布的影响很小。
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A pharmacokinetic study to evaluate the profile of droxicam in elderly healthy volunteers after a single oral dose of 20mg.

A single oral dose pharmacokinetic study in a group of 10 elderly healthy volunteers was performed to evaluate the pharmacokinetic profile and the potential effect of age on the absorption, distribution and elimination of droxicam. After complete medical screening, and informed written consent, one dose (20mg) of droxicam was administered to all volunteers, under medical supervision. A complete pharmacokinetic profile of the obtained blood plasma levels was evaluated over 120 hours. All volunteers completed the study and in none did droxicam cause intolerance or side effects. The results showed that droxicam absorption, distribution and elimination did not differ substantially from reference studies done with young healthy volunteers. The peak mean plasma concentration was at 10 hours 1.38 +/- 0.29 microgram/ml, declining slowly, reaching 0.24 +/- 0.20 microgram/ml at 120 hours, with a half life of 50.23 +/- 17.19 hours and an elimination rate constant of 0.015 +/- 0.005 microgram/ml.h-1. In comparison to the healthy, young volunteers, the variation was minimal. It can be concluded from this study that age causes minimal variations in the absorption and distribution of droxicam.

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