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©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 26, 2020; 8(22): 5518-5528
Published online Nov 26, 2020. doi: 10.12998/wjcc.v8.i22.5518
Published online Nov 26, 2020. doi: 10.12998/wjcc.v8.i22.5518
Bioequivalence of two esomeprazole magnesium enteric-coated formulations in healthy Chinese subjects
Zheng-Zhi Liu, Qing Ren, Yan-Nan Zhou, Hai-Miao Yang, Phase I Clinical Trial Laboratory, Affiliated Hospital of Changchun University of Chinese Medicine, Changchun 130021, Jilin Province, China
Author contributions: Liu ZZ, Yang HM, contributed equally to this work; Liu ZZ, Yang HM designed the research study; Liu ZZ, Ren Q, Zhou YN performed the research; Liu ZZ analyzed the data and wrote the manuscript; all authors have read and approved the final manuscript.
Institutional review board statement: The study protocol was approved by the Ethics Committee of Changchun University of Chinese Medicine Affiliated Hospital.
Informed consent statement: All participates provided written informed consent prior to study inclusion.
Conflict-of-interest statement: The authors declare no conflict of interest.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Hai-Miao Yang, MSc, Chief Doctor, Phase I Clinical Trial Laboratory, Affiliated Hospital of Changchun University of Chinese Medicine, No. 1478 Gongnong Road, Changchun 130021, Jilin Province, China. 315597629@qq.com
Received: June 5, 2020
Peer-review started: June 5, 2020
First decision: July 25, 2020
Revised: August 6, 2020
Accepted: September 8, 2020
Article in press: September 8, 2020
Published online: November 26, 2020
Processing time: 173 Days and 4 Hours
Peer-review started: June 5, 2020
First decision: July 25, 2020
Revised: August 6, 2020
Accepted: September 8, 2020
Article in press: September 8, 2020
Published online: November 26, 2020
Processing time: 173 Days and 4 Hours
Core Tip
Core Tip: The pharmacokinetic characteristics and bioequivalence of two types of single oral dose esomeprazole magnesium (Eso) enteric-coated capsules were assessed. The 90%CI of the ratios of geometric means of the primary pharmacokinetic parameters all fell within the acceptable limits of 80.00%-125.00%. Although meal was able to extend drug absorption, it had no impact on Cmax, AUC0-t, or AUC0-inf, of either of the two formulations under the same status. Furthermore, no significant differences in safety issues were observed between the two formulations. Therefore, the two formulations of Eso enteric-coated capsules are considered bioequivalence.