Martínez L, Sánchez J, Roser R, García-Barbal J, Bartlett A, Estruch J, Sagarra R, Puig S, Costa A
Dept. of Biochemistry, Laboratorios Dr. Esteve, S.A., Barcelona, Spain.
Methods Find Exp Clin Pharmacol. 1988 Nov;10(11):729-37.
A controlled, randomized, double-blind, clinical trial has been performed in healthy volunteers in order to study the pharmacokinetics and tolerability of droxicam in comparison with piroxicam, when both drugs were administered at a dose of 20 mg/day for 20 days. Since transformation into piroxicam takes place in the gastrointestinal tract, unchanged droxicam was not detected in plasma. Steady state of plasma piroxicam concentrations was reached in all volunteers during the course of the study. Absorption kinetics of droxicam were delayed with respect to those of piroxicam (t1/2 a = 7.55 h for droxicam and 1.78 h for piroxicam). The remaining pharmacokinetical parameters studied showed no statistically significant differences. The bioavailability of both drugs was equal. Tolerability of droxicam and piroxicam was as usual for the NSAIDs, and no clinical or analytical side effects which could hinder its administration to wider populations were detected. Statistically significant differences in the number and type of side effects detected in the two treatment groups were not encountered.
为了研究当两种药物均以20毫克/天的剂量给药20天时，屈昔康与吡罗昔康相比的药代动力学和耐受性，在健康志愿者中进行了一项对照、随机、双盲临床试验。由于在胃肠道中会转化为吡罗昔康，因此在血浆中未检测到未变化的屈昔康。在研究过程中，所有志愿者的血浆吡罗昔康浓度均达到稳态。与吡罗昔康相比，屈昔康的吸收动力学延迟（屈昔康的t1/2 a = 7.55小时，吡罗昔康为1.78小时）。所研究的其余药代动力学参数无统计学显著差异。两种药物的生物利用度相同。屈昔康和吡罗昔康的耐受性与非甾体抗炎药通常情况一样，未检测到可能妨碍其应用于更广泛人群的临床或分析性副作用。在两个治疗组中检测到的副作用数量和类型没有统计学显著差异。
