Publication: Clinical Pharmacology in Drug Development
Abstract
This study investigated the association between esomeprazole pharmacokinetics and CYP2C19 gene polymorphisms in 95 healthy Chinese participants receiving 20 or 40 mg oral esomeprazole, genotyped as poor, intermediate, or rapid metabolizers. Plasma esomeprazole was quantified by HPLC-UV and pharmacokinetic parameters calculated using Phoenix WinNonlin. Significant differences were found between CYP2C19 genotype groups in terminal half-life, dose-normalized Cmax, and dose-normalized AUC, confirming that esomeprazole metabolism is strongly influenced by CYP2C19 polymorphisms. No unexpected adverse events occurred at either dose, supporting esomeprazole's established safety profile across CYP2C19 phenotypes.
Author(s): Fang Y, He X, Peng A, Yang YQ, Xiang J
Published: 2023 年 9 月 29 日
Phoenix WinNonlin: Genotype-Linked PK Differences
Phoenix WinNonlin's pharmacokinetic analysis confirmed that CYP2C19 genotype significantly shapes esomeprazole exposure across metabolizer groups in this study. Within a Phoenix platform that has trained more than 9,000 people, Phoenix WinNonlin's output can become submission-ready tables, figures, and listings through TFL Studio.
