{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T16:26:54Z","timestamp":1788280014452,"version":"build-2803163510"},"reference-count":20,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T00:00:00Z","timestamp":1714694400000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Fexuprazan, a novel potassium\u2010competitive acid blocker, is expected to be used for the prevention of nonsteroidal anti\u2010inflammatory drugs (NSAIDs) induced ulcer. This study aimed to evaluate pharmacokinetic (PK) interactions between fexuprazan and NSAIDs in healthy subjects. A randomized, open\u2010label, multicenter, six\u2010sequence, one\u2010way crossover study was conducted in healthy male subjects. Subjects randomly received one of the study drugs (fexuprazan 40\u2009mg BID, celecoxib 200\u2009mg BID, naproxen 500\u2009mg BID, or meloxicam 15\u2009mg QD) for 5 or 7\u2009days in the first period followed by the combination of fexuprazan and one of NSAIDs for the same days and the perpetrator additionally administered for 1\u20132\u2009days in the second period. Serial blood samples for PK analysis were collected until 48\u2010 or 72\u2010h post\u2010dose at steady state. PK parameters including maximum plasma concentration at steady state (<jats:italic>C<\/jats:italic><jats:sub>max,ss<\/jats:sub>) and area under plasma concentration\u2013time curve over dosing interval at steady state (AUC<jats:sub>\u03c4,ss<\/jats:sub>) were compared between monotherapy and combination therapy. The PKs of NSAIDs were not significantly altered by fexuprazan. For fexuprazan, differences in PK parameters (22% in <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>, 19% in AUC<jats:sub>\u03c4,ss<\/jats:sub>) were observed when co\u2010administered with naproxen, but not clinically significant. The geometric mean ratio (90% confidence interval) of combination therapy to monotherapy for <jats:italic>C<\/jats:italic><jats:sub>max,ss<\/jats:sub> and AUC<jats:sub>\u03c4,ss<\/jats:sub> was 1.22 (1.02\u20131.46) and 1.19 (1.00\u20131.43), respectively. There were no significant changes in the systemic exposure of fexuprazan by celecoxib and meloxicam. Fexuprazan and NSAIDs did not show clinically meaningful PK interactions.<\/jats:p>","DOI":"10.1111\/cts.13798","type":"journal-article","created":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T12:49:06Z","timestamp":1714740546000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacokinetic interactions between fexuprazan, a potassium\u2010competitive acid blocker, and nonsteroidal anti\u2010inflammatory drugs in healthy males"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7385-4785","authenticated-orcid":false,"given":"Heejae","family":"Won","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Korea"},{"name":"Department of Biomedical Sciences Seoul National University College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8568-7320","authenticated-orcid":false,"given":"Eunwoo","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jihye","family":"Chae","sequence":"additional","affiliation":[{"name":"Daewoong Pharmaceutical Co., Ltd.  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