Kozjek F, Mrhar A, Kmetec V, Primozic S, Karba R, Janezic A, Jerman P
Int J Clin Pharmacol Ther Toxicol. 1987 Jun;25(6):313-6.
The aim of the work is to evaluate the bioequivalence of piroxicam administered orally and rectally in 20 mg dose every 24 hours. The corresponding "in vivo" study was undertaken and plasma samples were collected during the ninth dosing interval. HPLC method was used for piroxicam plasma concentrations determination. AUC and C were calculated and the obtained data were statistically analyzed. Analog-hybrid simulation was used to confirm additionally the similarity between the discussed formulations. No significant differences were observed using paired t-test and two-way analysis of variance while the methods of Hauck and Westlake, looking strictly, gave nonbioequivalence. Simulated response of one compartment model is suitable for "in vivo" data in both cases. Measured and simulated average steady state concentrations are equal and in complete accordance with those given in literature. Finally it can be concluded that oral and rectal application are bioequivalent in the sense of expected clinical effects.
本研究的目的是评估每24小时口服和直肠给予20mg剂量吡罗昔康的生物等效性。进行了相应的“体内”研究,并在第九个给药间隔期间采集血浆样本。采用高效液相色谱法测定吡罗昔康血浆浓度。计算AUC和C,并对所得数据进行统计分析。使用模拟-混合模拟进一步确认所讨论制剂之间的相似性。使用配对t检验和双向方差分析未观察到显著差异,而严格来看,Hauck和Westlake方法给出了非生物等效性结果。在两种情况下,一室模型的模拟响应均适用于“体内”数据。测量和模拟的平均稳态浓度相等,且与文献中给出的浓度完全一致。最后可以得出结论,从预期的临床效果来看,口服和直肠给药具有生物等效性。