Dosing regimen selection for pazufloxacin tablet in clinical trial based on its pharmacokinetic/pharmacodynamic analysis

VernacularTitle:抗菌药物药代动力学／药效学分析用于帕珠沙星临床试验中给药方案的指导
Author: Min-Ji WEI ¹ ; Cai-Yun ZHAO ; Xiang-Lin CAO ; Yuan LV
Author Information

1. 北京大学第一医院临床药理研究所
Keywords: pazufloxacin; Monte Carol simulation; dosing regimen
From: The Chinese Journal of Clinical Pharmacology 2015;(24):2420-2422
CountryChina
Language:Chinese
Abstract: Objective To predict the possible dosing regimen for the clinical study of pazufloxacin.Methods Based on the pharmacokinetic parameters of pazufloxacin, its protein binding rates and bacterium sus-ceptible data, the probability of target attainment( PTA) was calculated at different pharmacokinetic/pharmacodynamic ( PK/PD ) target values through Monte Carol simulation and was compared with the values of reference drug levofoxacin.Results The results showed the PTAs of daily dose of 1000 mg pazufloxacin to similar pathogens was comparable with that of daily dose of 750 mg of levofloxacin.Conclusion Based on the simulated data, 500 mg bid of pazufloxacin was recommended for the further clinical studies.