Prediction of Drug-Drug Interaction Potential of Tegoprazan Using Physiologically Based Pharmacokinetic Modeling and Simulation.

ABSTRACT: This study aimed to develop a physiologically based pharmacokinetic (PBPK) model of tegoprazan and to predict the drug-drug interaction (DDI) potential between tegoprazan and cytochrome P450 (CYP) 3A4 perpetrators. The PBPK model of tegoprazan was developed using SimCYP Simulator® and verified by comparing the model-predicted pharmacokinetics (PKs) of tegoprazan with the observed data from phase 1 clinical studies, including DDI studies. DDIs between tegoprazan and three CYP3A4 perpetrators were predicted by simulating the difference in tegoprazan exposure with and without perpetrators, after multiple dosing for a clinically used dose range. The final PBPK model adequately predicted the biphasic distribution profiles of tegoprazan and DDI between tegoprazan and clarithromycin. All ratios o

SUBMITTER: Yoon DY 

PROVIDER: S-EPMC8464955 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature