A randomized, open-label, single-dose study to evaluate the safety and pharmacokinetics of two formulations containing 40 mg of fexuprazan in healthy Korean subjects

The novel 40-mg fexuprazan formulation (tablet A) was demonstrated to be bioequivalent to the initially developed formulation (tablet B), with comparable systemic exposure (AUC) and peak concentration (C<sub>max</sub>). Both formulations were well tolerated, with no clinically meaningful differences in adverse event profiles.

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Publication Details

Journal
International Journal of Clinical Pharmacology and Therapeutics
Published
2026-02-22
DOI
https://doi.org/10.5414/cp204926
Primary Topic
Pharmacological Receptor Mechanisms and Effects
Type
article
Field-Weighted Citation Impact
0.00
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article

A randomized, open-label, single-dose study to evaluate the safety and pharmacokinetics of two formulations containing 40 mg of fexuprazan in healthy Korean subjects

Seol Ju Moon, Min-Gul Kim, Yong-Geun Kwak, Joon Hur et al.
International Journal of Clinical Pharmacology and Therapeutics
Pharmacological Receptor Mechanisms and Effects
article

A randomized, open-label, single-dose study to evaluate the safety and pharmacokinetics of two formulations containing 40 mg of fexuprazan in healthy Korean subjects

Seol Ju Moon, Min-Gul Kim, Yong-Geun Kwak, Joon Hur, Jin A Lee, Jihye Chae, Yongam Choi, Hyung Seok Park
article en

Abstract

The novel 40-mg fexuprazan formulation (tablet A) was demonstrated to be bioequivalent to the initially developed formulation (tablet B), with comparable systemic exposure (AUC) and peak concentration (C<sub>max</sub>). Both formulations were well tolerated, with no clinically meaningful differences in adverse event profiles.

International Journal of Clinical Pharmacology and Therapeutics
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Openalex Percentile: Top 46%
Pharmacological Receptor Mechanisms and Effects
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