Abstract: AIM: To establish the population pharmacokinetics (PPK) model of faropenem sodium tablets by oral administration in Chinese healthy adults, evaluate the pharmacokinetics characteristics of faropenem, and investigate the factors which could influence the pharmacokinetics of faropenem. METHODS: Based on the clinical research data of faropenem obtained from two clinical research centers using Chinese healthy adult volunteers, the population pharmacokinetics model was executed by using Phoenix NLME software, and validated by VPC method and bootstrap procedure. RESULTS: A one-compartment model with first-order elimination pharmacokinetics with lag time provided the best fit for faropenem. Inter-individual variability could be described by exponential model. The clearance (CL/F) and volume of distribution(V/F) were 650.68 mL·h^-1·kg^-1,594.24 mL/kg were 650.68 mL·h^-1,594.24 mL/kg,respectively. CONCLUSION: The population pharmacokinetic parameters of faropenem were mainly offected by diet and gender. The established could estimate individual and population pharmacokinetic parameters of Chinese healthy adults, and drawn in favor of reasonable treatment regimen.

Key words: faropenem, population pharmacokinetics, food effect, NONMEM