Pharmacokinetics of once daily prolonged-release formulation of tacrolimus in pediatric nephrotic syndrome recipients: a open-label single-center phase Ⅱtrail
Background and Objectives Tacrolimus PR is a new prolonged-release once-daily formulation of the calcineurin inhibitor tacrolimus,currently used in adult transplant patients extensively.As there are no pharmacokinetic data available in pediatric nephrotic syndrome recipients,the aims of this study were to develop a pharmacokinetic study of tacrolimus PR in pediatric nephrotic syndrome recipients Methods Pharmacokinetic samples were collected from 8 pediatric nephrotic syndrome patients.Pharmacokinetic analysis was performed using WinNolin Phoenix (Version 6.0,Pharsight,Cary,NC).Results The pharmacokinetic data were best described by a non-compartment model,and the main data of three different dose dosage groups are showed as follows:Group A(0.02mg/kg): Cmax 1.69±0.99 ng·ml-1,AUC0-t 47.21±47.07 h·ng·ml-1,CL/F 0.81±0.91 L·kg-1·h-1; Group B(0.05mg/kg): Cmax 3.12±1.86 ng·ml-1,AUC0-t 83.99±13.13 h·ng·ml-1 CL/F 0.41±0.06 L·kg-1·h-1 ;Group C( 0.10mg/kg): Cmax 7.97±3.53 ng·ml-1,AUC0-t 175.57±107.11 h·ng·ml-1 CL/F 1.88±1.25 L·kg-1·h-1.Furthermore,the weight normalized distribution volume V/F was 6.99±3.37 L·kg -1,12.35±8.42 L·kg -1,and 73.60±68.64 L·kg -1 separately.Conclusions The pharmacokinetic characteristic of tacrolimus PR was validated in pediatric nephrotic syndrome patients.The developed data information could be useful to optimize individual pediatric tacrolimus PR dosing regimen in pediatric nephrotic syndrome therapy practice.
Tacrolimus Once daily Prolonged-release formulation Pediatrics Pediatric pharmacology
国内会议
南昌
英文
1-8
2013-06-14（万方平台首次上网日期，不代表论文的发表时间）