健康人体的肌酐清除率对氯吡格雷的药代动力学影响

The effect of creatinine clearance rate on the clopidogrel pharmacokinetics among healthy volunteers

目的研究健康人体不同内生肌酐清除率水平对氯吡格雷药代动力学的影响。方法 32名健康青年受试者,根据内生肌酐清除率由低到高的顺序分成3组,空腹口服氯吡格雷75 mg。用高效液相色谱-质谱联用测定血药浓度;用Watson LIMS 7.3软件计算药代动力学参数。结果氯吡格雷的主要药代动力学参数以及不良事件发生情况,3组间差异均无统计学意义(P>0.05)。结论健康青年人群不同内生肌酐清除率水平对氯吡格雷的药代动力学参数没有影响。

Objective To investigate the effect of different endogenous creatinine clearance rate（CCr） on clopidogrel pharmacokinetics among the healthy volunteers.Methods 32 subjects were selected in clopidogrel pharmacokinetics study.All the subjects were divided into three groups according to CCr value.All the volunteers took a single oral dose of 75 mg Clopidogrel tablet under fast condition.The drug concentrations were determined by LC-MS-MS method.The pharmacokinetics parameters were calculated by Watson LIMS 7.3 software.Results There were no differences among the three groups in pharmacokinetic parameters of clopidogrel（P0.05）,and neither were the adverse events.Conclusion The pharmacokinetic parameters of clopidogrel were not effected by CCr value among these healthy volunteers with normal renal function.