Kees F, Wellenhofer M, Bröhl K, Grobecker H
Lehrstuhl für Pharmakologie, Universität Regensburg, Germany.
Arzneimittelforschung. 1996 Apr;46(4):435-8.
In a cross-over study on twelve healthy volunteers cefpodoxime proxetil (CAS 87239-81-4) and acetylcysteine (CAS 616-91-1) were evaluated for possible pharmacokinetic interactions. After a standardized breakfast, the subjects received p.o. either 200 mg cefpodoxime administered as cefpodoxime proxetil (reference) or 200 mg cefpodoxime and 200 mg acetylcysteine (test). To determine the pharmacokinetic profile of cefpodoxime the plasma concentrations were determined by HPLC. The plasma concentration-time curve of cefpodoxime was very similar after both regimens, and with respect to cefpodoxime bioequivalence has been proven. The narrow range of 90% confidence intervals for the quotient test/reference for Cmax and AUC indicate reliable bioavailability of cefpodoxime proxetil independent of co-administered acetylcysteine.
在一项针对12名健康志愿者的交叉研究中,对头孢泊肟酯(CAS 87239-81-4)和乙酰半胱氨酸(CAS 616-91-1)可能存在的药代动力学相互作用进行了评估。在食用标准早餐后,受试者口服200 mg以头孢泊肟酯形式给药的头孢泊肟(参比制剂)或200 mg头孢泊肟与200 mg乙酰半胱氨酸(受试制剂)。为了确定头孢泊肟的药代动力学特征,采用高效液相色谱法测定血浆浓度。两种给药方案后头孢泊肟的血浆浓度-时间曲线非常相似,并且已证明头孢泊肟具有生物等效性。Cmax和AUC的受试制剂/参比制剂商数的90%置信区间范围较窄,表明头孢泊肟酯具有可靠的生物利用度,与同时服用的乙酰半胱氨酸无关。