{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T01:21:49Z","timestamp":1789608109885,"version":"build-2803163510"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T00:00:00Z","timestamp":1760313600000},"content-version":"vor","delay-in-days":12,"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":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Envlo (enavogliflozin) 0.3\u2009mg, an SGLT2 inhibitor, was approved in Korea in 2022 for glycemic control in type 2 diabetes (T2DM). This study evaluates its safety, pharmacokinetics, and food effects. Healthy subjects (age\u2009\u2265\u200919, weight\u2009\u2265\u200950.0\u2009kg, body mass index (BMI) 18.0\u201330.0\u2009kg\/m\n                    <jats:sup>2<\/jats:sup>\n                    ) were enrolled. Study I was a randomized, two\u2010way crossover study with an 8\u2010day washout, where subjects received either a separate or a fixed\u2010dose combination (FDC) of enavogliflozin 0.3\u2009mg\/gemigliptin 50\u2009mg. Study II, a randomized, open\u2010label, two\u2010way crossover design with a 7\u2010day washout, compared the food effect of a single dose of enavogliflozin in fed versus fasted after a high\u2010fat meal. In study I, enavogliflozin reached peak plasma concentration at 1.25\u2009h (median) in both groups. The mean half\u2010life (\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>1\/2<\/jats:sub>\n                    ) was also comparable, recorded as 12.56\u2009\u00b1\u20094.04\u2009h for the separate combination and 12.23\u2009\u00b1\u20093.46\u2009h for the FDC. Gemigliptin peaked at 2.00\u2009h in the separate combination and at 3.00\u2009h in the FDC. The mean\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>1\/2<\/jats:sub>\n                    was 18.04\u2009\u00b1\u20091.75\u2009h for the separate combination and 18.67\u2009\u00b1\u20092.54\u2009h for the FDC. In study II, the plasma concentration of enavogliflozin 0.3\u2009mg peaked at 1.25 and 2.00\u2009h (median), indicating a delayed\n                    <jats:italic>T<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    in the fed group. The average\n                    <jats:italic>t<\/jats:italic>\n                    <jats:sub>1\/2<\/jats:sub>\n                    was similar at 12.49\u2009\u00b1\u20092.12\u2009h and 12.30\u2009\u00b1\u20092.81\u2009h, respectively. The FDC of enavogliflozin and gemigliptin demonstrated pharmacokinetic equivalence and comparable safety to their co\u2010administration as separate agents. Furthermore, the systemic exposure of enavogliflozin was not affected by food intake, supporting its potential for flexible, meal\u2010independent use in clinical settings.\n                  <\/jats:p>","DOI":"10.1111\/cts.70376","type":"journal-article","created":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T05:17:17Z","timestamp":1760419037000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics and Safety of Fixed\u2010Dose Versus Separate Enavogliflozin\/Gemigliptin Combinations, and Food Effect on Enavogliflozin in Healthy Korean Subjects"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2476-2408","authenticated-orcid":false,"given":"Young\u2010Sim","family":"Choi","sequence":"first","affiliation":[{"name":"Cheongju Osong National Advanced Clinical Trial Center ChungBuk National University Hospital  Cheongju\u2010si Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"JAEJIN","family":"NA","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Design &amp; Evaluation, SAIHST Sungkyunkwan University  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8476-6769","authenticated-orcid":false,"given":"Seo Yeong","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology ChungBuk National University College of Medicine  Cheongju\u2010si Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae Min","family":"Cho","sequence":"additional","affiliation":[{"name":"Daewoong Pharmaceutical Co., Ltd.  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoonhye","family":"Jeong","sequence":"additional","affiliation":[{"name":"Daewoong Pharmaceutical Co., Ltd.  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun Gi","family":"Hwang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology ChungBuk National University College of Medicine  Cheongju\u2010si Republic of Korea"},{"name":"Department of Clinical Pharmacology and Therapeutics ChungBuk National University Hospital  Cheongju\u2010si Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,13]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"World Health Organization Classification of Diabetes Mellitus(2019) Date: 2019\u201006\u201011."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(23)01301\u20106"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2522\/ptj.20080020"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc24\u2010S009"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc23\u2010S009"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc22\u2010S009"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125\u2010017\u20104318\u2010z"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/2042018820980225"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0806470"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1210\/er.2014\u20101035"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15348"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15632"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2010.512"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010019\u20101057\u20100"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.4093\/dmj.2022.0315"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.15046"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.15537"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463\u20101326.2010.01314.x"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12741"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc16\u20101347"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2016.1215427"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13294"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabet.2018.01.011"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.5414\/cp201948"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13593"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262\u2010013\u20100126\u2010x"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13340\u2010011\u20100037\u20108"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463\u20101326.2011.01397.x"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100043\u2010104779"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70376","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,25]],"date-time":"2025-10-25T05:31:59Z","timestamp":1761370319000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70376"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":29,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1111\/cts.70376"],"URL":"https:\/\/doi.org\/10.1111\/cts.70376","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"2025-04-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70376"}}