Association Study of Esomeprazole Pharmacokinetics and CYP2C19 Gene Polymorphisms.

Autor: Fang Y; Department of Gastroenterology, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Department of Clinical Research Management, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China., He X; Department of Gastroenterology, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Department of Clinical Research Management, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Clinical Trial Center, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China., Peng A; Department of Gastroenterology, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Department of Clinical Research Management, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Clinical Trial Center, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China., Yang YQ; Department of Forensic Toxicological Analysis, West China School of Basic Medical Sciences & Forensic Medicine, Sichuan University, Wuhou, Chengdu, P.R. China., Xiang J; Department of Gastroenterology, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Department of Clinical Research Management, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; Clinical Trial Center, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.; NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, Wuhou, Chengdu, P.R. China.
Jazyk: angličtina
Zdroj: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Feb; Vol. 13 (2), pp. 134-139. Date of Electronic Publication: 2023 Sep 29.
DOI: 10.1002/cpdd.1334
Abstrakt: To investigate the association between esomeprazole pharmacokinetics and CYP2C19 gene polymorphisms in a cohort of 95 healthy Chinese participants. A cohort of 95 participants was assembled and stratified into 2 distinct groups, receiving either 20 or 40 mg of esomeprazole through oral administration. The subjects encompassed 17 poor metabolizers, 47 intermediate metabolizers, and 31 rapid metabolizers, and their genotypes were ascertained using the polymerase chain reaction-restriction fragment length polymorphism technique. Esomeprazole plasma concentrations were quantified employing a high-performance liquid chromatography-ultraviolet method. Pharmacokinetic parameters were computed via Phoenix WinNonlin 6.1 software, while SPSS 26.0 facilitated statistical analysis to contrast the pharmacokinetics and the CYP2C19 genotypes. In the aftermath of administering 20 or 40 mg esomeprazole, marked differences were discerned between terminal elimination half-life, maximum concentration/dose, and area under the plasma concentration-time curve from time zero to infinity/dose of esomeprazole (P < .05), with the exception of time to maximum concentration. The findings of this investigation signify a significant association between esomeprazole metabolism and CYP2C19 gene polymorphisms. There were no unprecedented adverse events documented subsequent to the administration of 20 and 40 mg esomeprazole dosages. Esomeprazole has manifested promising safety and tolerability profiles in pertinent clinical trials.
(© 2023 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)
Databáze: MEDLINE
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