Krause W, Schuhmann-Giampieri G, Staks T, Kaufmann J
Schering AG, Kontrastmittelforschung, Berlin, Germany.
Eur J Clin Pharmacol. 1994;46(4):339-43. doi: 10.1007/BF00194402.
Twelve healthy male volunteers participated in a single-blind, randomised, placebo-controlled cross-over study of i.v. iopromide in doses of 15 g iodine or 80 g iodine infused over a period of 15 min. The volunteers were observed for three days during which time blood samples, urine and faeces were collected. The terminal disposition phase half-life of iopromide was 2 h and 1.9 h, and the total clearance was 110 and 103 ml.min-1 at the lower and at the higher dose levels, respectively. The steady state volume of distribution was 16 and 17 l, indicating predominantly extracellular distribution of iopromide. Statistical analysis (one-sided t-test) showed that all the target parameters (AUC, half-life and urinary excretion) were equivalent at both dose levels, indicating dose proportionate, first order kinetics of iopromide over the large dose range tested. Iopromide was well tolerated after both doses.
12名健康男性志愿者参与了一项单盲、随机、安慰剂对照的交叉研究，静脉注射碘普罗胺，剂量分别为15克碘或80克碘，输注时间为15分钟。对志愿者进行了为期三天的观察，在此期间采集了血液样本、尿液和粪便。碘普罗胺的终末处置相半衰期分别为2小时和1.9小时，低剂量和高剂量水平下的总清除率分别为110和103毫升·分钟⁻¹。稳态分布容积为16升和17升，表明碘普罗胺主要分布于细胞外。统计分析（单侧t检验）表明，两个剂量水平下所有目标参数（AUC、半衰期和尿排泄）均相当，表明在测试的大剂量范围内碘普罗胺呈剂量比例的一级动力学。两种剂量的碘普罗胺耐受性均良好。
