{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:18:48Z","timestamp":1787663928515,"version":"build-2736575974"},"reference-count":22,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T00:00:00Z","timestamp":1787443200000},"content-version":"vor","delay-in-days":22,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Rabeprazole is a highly variable drug for which demonstration of bioequivalence is often challenging, and CYP2C19 genotype and sex have been suggested as potential contributors to pharmacokinetic variability. We evaluated the pharmacokinetics, bioequivalence (BE), and tolerability of a generic rabeprazole formulation compared with the reference product in healthy Korean participants using an open\u2010label, randomized, single\u2010dose, two\u2010sequence, four\u2010period replicated crossover design with a scaled average BE (SABE) approach. Exploratory subgroup analyses according to CYP2C19 genotype and sex were also performed. Fifty\u2010two participants received single 20\u00a0mg doses under fasting conditions, and 46 completed the trial. BE was evaluated using SABE and conventional average BE (ABE), with subgroup analyses by genotype and sex. Geometric mean ratios (GMRs) of the test to reference formulations were within the BE acceptance range under ABE and SABE approaches. The reference formulation showed high intra\u2010CV in maximum plasma concentration (\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ; 67.9%), consistent with the classification of rabeprazole as a highly variable drug. These results demonstrated bioequivalence between the test and reference formulations under both conventional average bioequivalence and scaled bioequivalence approaches.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70099","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T06:11:27Z","timestamp":1787551887000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence of two rabeprazole formulations and pharmacokinetic variability by CYP2C19 genotype and sex in healthy Korean participants: A four\u2010period replicated crossover study"],"prefix":"10.1002","volume":"15","author":[{"given":"Nakyong","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Clinical Medical Sciences Seoul National University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joo\u2010Youn","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences Seoul National University College of Medicine  Seoul Republic of Korea"},{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Hospital  Seoul Republic of Korea"},{"name":"Kidney Research Institute Seoul National University Medical Research Center  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byungwook","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Pharmacology Kangwon National University School of Medicine  Chuncheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,23]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"EISAI Co. 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