{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T13:29:22Z","timestamp":1761744562724},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2017,8,7]],"date-time":"2017-08-07T00:00:00Z","timestamp":1502064000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Taisho Pharmaceutical Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This open\u2010label, parallel\u2010group study evaluated the effect of mild and moderate hepatic impairment on the pharmacokinetics of a single dose of luseogliflozin in Japanese subjects. Thirteen subjects with hepatic impairment (mild, n = 8; moderate, n = 5) and 6 healthy subjects received a single 5\u2010mg dose of luseogliflozin. Serial blood sampling over 72 hours and 24\u2010hour urine collection were done for pharmacokinetic analysis of luseogliflozin and its metabolites and to measure pharmacokinetic and pharmacodynamic parameters, respectively. Demographic characteristics were similar at baseline for both groups. Geometric mean ratios of maximum plasma concentration (C<jats:sub>max<\/jats:sub>) and area under the plasma concentration\u2013time curve from time zero to infinity (AUC<jats:sub>inf<\/jats:sub> [90%CI]) of unchanged luseogliflozin were 1.02 (0.790\u20131.32) and 0.774 (0.580\u20131.03), respectively, on comparing patients with hepatic impairment with healthy subjects, and 0.939 (0.752\u20131.17) and 1.00 (0.780\u20131.28), respectively, in subjects with mild and moderate hepatic impairment. Although mean plasma concentrations of metabolites were slightly higher in patients with hepatic impairment versus healthy subjects, their time\u2010course plasma concentrations were very low compared with those of unchanged luseogliflozin. Single\u2010dose luseogliflozin 5 mg was well tolerated by study participants, indicating luseogliflozin dose adjustment is not necessary in patients with mild and moderate hepatic impairment.<\/jats:p>","DOI":"10.1002\/cpdd.364","type":"journal-article","created":{"date-parts":[[2017,8,7]],"date-time":"2017-08-07T16:52:39Z","timestamp":1502124759000},"page":"439-447","source":"Crossref","is-referenced-by-count":14,"title":["Luseogliflozin, an SGLT2 Inhibitor, in Japanese Patients With Mild\/Moderate Hepatic Impairment: A Pharmacokinetic Study"],"prefix":"10.1002","volume":"6","author":[{"given":"Yoshishige","family":"Samukawa","sequence":"first","affiliation":[{"name":"Taisho Pharmaceutical Co. Ltd.  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Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soichi","family":"Sakai","sequence":"additional","affiliation":[{"name":"Taisho Pharmaceutical Co. Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Kumagai","sequence":"additional","affiliation":[{"name":"Kitasato University School of Medicine  Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,8,7]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1440-1746.2002.02755.x"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.4254\/wjh.v3.i5.99"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1478-3231.2009.02191.x"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.15.280"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm901893x"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2011.01340.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2014.912983"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2014.909390"},{"issue":"4","key":"e_1_2_9_10_1","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1080\/00498254.2016.1193263","article-title":"Metabolite profiling and enzyme reaction phenotyping of luseogliflozin, a sodium\u2013glucose cotransporter 2 inhibitor, in humans","volume":"47","author":"Miyata A","year":"2017","journal-title":"Xenobiotica"},{"issue":"4","key":"e_1_2_9_11_1","doi-asserted-by":"crossref","first-page":"314","DOI":"10.1080\/00498254.2016.1193913","article-title":"In vitro evaluation of potential drug interactions mediated by cytochrome P450 and transporters for luseogliflozin, an SGLT2 inhibitor","volume":"47","author":"Chino Y","year":"2017","journal-title":"Xenobiotica"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-014-0102-3"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-015-0209-1"},{"key":"e_1_2_9_14_1","unstructured":"SasakiT SeinoY SamukawaY SakaiS WatanabeT.Effect of gender and age on the pharmacokinetics of luseogliflozin (TS\u2010071) a selective SGLT2 inhibitor [ADA 2012 Philadelphia]. 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