摘要
目的考察克拉霉素片的人体相对生物利用度。方法对20名健康受试者采用单剂量、随机、交叉对照试验设计,空腹口服克拉霉素片试验制剂和参比制剂各500mg后,以高效液相色谱(HPLC)法检测血浆中克拉霉素经时过程的血药浓度,计算其药代动力学参数和相对生物利用度。结果克拉霉素受试制剂相对于参比制剂的生物利用度为(98.0±24.2)%,方差分析和双单侧t检验显示受试制剂和参比制剂的AUC0→∞和Cmax无显著性差异(P>0.05),克拉霉素受试制剂的AUC0→∞和Cmax的90%置信区间分别为87.2%～102.4%和92.6%～116.4%。结论克拉霉素受试制剂和参比制剂具有生物等效性。
Objective To observe the relative bioavailability of clarithromycin tablets in healthy volunteers. Methods In a randomized two- period cross-over study,a single oral dose of 500 mg clarithromycin tablets （tested and referenced preparations） was given to 20 healthy volunteers. The plasma concentrations of clarithromycin were determined by HPLC. The pharmacokinetic parameters of two preparations and the relative bioavailability of clarithromycin were calculated with statistical analysis. Results The relative bioavailability of clarithromycin in the tested preparation was （98.0 ±24.2）%. There was no significant difference in the pharmacokinetic parameters between the tested and referenced preparations （ P 〉 0. 05）. The 90% confidence interval of AUC0→∞ was 87.2% - 102. 4% , C was 92. 6% - 116. 4%. Conclusion The two kinds of clarithromycin are bioequivalent.
出处
《中国药业》
CAS
2008年第21期12-14,共3页
China Pharmaceuticals
