Hosie J, Kelly J, Sánchez J, Bartlett A, Harrison F J
Institute of Biopharmaceuticals, Athlone.
Eur J Rheumatol Inflamm. 1991;11(4):45-9.
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.
在一组10名老年健康志愿者中进行了单次口服剂量药代动力学研究，以评估药代动力学特征以及年龄对droxicam吸收、分布和消除的潜在影响。在完成医学筛查并获得知情书面同意后，在医学监督下给所有志愿者服用一剂（20mg）droxicam。在120小时内评估所获得的血浆水平的完整药代动力学特征。所有志愿者均完成了研究，且droxicam在任何志愿者中均未引起不耐受或副作用。结果表明，droxicam的吸收、分布和消除与针对年轻健康志愿者进行的参考研究相比没有实质性差异。平均血浆峰浓度在10小时时为1.38±0.29微克/毫升，缓慢下降，在120小时时达到0.24±0.20微克/毫升，半衰期为50.23±17.19小时，消除速率常数为0.015±0.005微克/毫升·小时-1。与健康年轻志愿者相比，差异最小。从这项研究可以得出结论，年龄对droxicam的吸收和分布影响极小。
