Population pharmacokinetic modeling of ilaprazole in healthy subjects and patients with duodenal ulcer in China

Ilaprazole is a proton pump inhibitor used to treat duodenal ulcers, but no population pharmacokinetic model existed to quantify how patient characteristics affect its disposition in Chinese populations. This study pooled data from four Phase I trials and one Phase IIa trial in healthy subjects and duodenal ulcer patients to build a population pharmacokinetic model using Phoenix NLME 8.3. Body weight and sex were identified as significant covariates for peripheral volume of distribution and clearance respectively, and disease status (healthy versus ulcer patient) significantly affected both parameters. This first Chinese population pharmacokinetic model for ilaprazole offers a validated framework to support future dosing research for this proton pump inhibitor.