摘要
20名健康受试者随机交叉单剂量和多剂量口服两种克拉霉素缓释片。采用LC-MS/MS法测定血浆中药物浓度,评价两种制剂的生物等效性。单剂量和多剂量试验结果表明,受试制剂的相对生物利用度为(112.2±49.8)%和(115.5±63.3)%,经方差分析和双单侧t检验,两制剂具有生物等效性。
According to a randomized crossover design, the pharmacokinetics and bioequivalence of 20 healthy male volunteers after oral administration of the single- and multiple-dose of two brands of clarithromycin sustainedrelease tablets were investigated. The concentration of clarithromycin in plasma was determined by LC-MS/MS. The relative bioavailabilities of the test tablets for single- and multiple-dose were （112.2±49.8） % and （115.5±63.3） %. The results of ANOVA and two one-side t-test indicated that the two preparations were bioequivalent.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2010年第5期356-359,共4页
Chinese Journal of Pharmaceuticals
基金
国家"重大新药创制"项目(No.2008ZX09312-001
2009ZX09311-002
2009ZX09103-372)
