{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T05:54:37Z","timestamp":1790834077239,"version":"4.1.0"},"reference-count":12,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"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":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The objective of the current study was to evaluate the rate and extent of absorption, and confirm the bioequivalence of a test formulation and a reference formulation of febuxostat 40\u00a0mg tablets in healthy Chinese subjects under both fasting and fed conditions. An open\u2010label, randomized, single\u2010dose, single\u2010center, two\u2010sequence, two\u2010period crossover Phase I study was implemented to assess the pharmacokinetic bioequivalence of the two formulations in 64 healthy volunteers (32 for fasting group, 32 for fed group). Subjects received a single oral dose of either the test or reference febuxostat 40\u00a0mg tablet under the corresponding condition, with a 7\u2010day washout period between cycles. The geometric mean ratios and their 90% confidence intervals (CIs) of the peak plasma concentration (), area under the plasma concentration\u2013time curve from time 0 to the last quantifiable time point (), and area under the plasma concentration\u2013time curve from time 0 to infinity () for the test versus reference formulation were calculated for bioequivalence evaluation. All 90% CIs fell within the pharmacokinetic bioequivalence acceptance range of 80%\u2013125%. A total of 12 adverse events (AEs) were reported in 10 subjects in the fasting group and nine AEs in eight subjects in the fed group, all of which were mild in severity with no serious AEs observed. The test formulation of febuxostat 40\u00a0mg tablets was bioequivalent to the reference formulation in healthy Chinese subjects under both fasting and fed conditions, and both formulations were well tolerated.<\/jats:p>","DOI":"10.1002\/cpdd.70104","type":"journal-article","created":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T04:54:51Z","timestamp":1790830491000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and Bioequivalence Evaluation of Febuxostat 40\u00a0mg Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Ying","family":"Cao","sequence":"first","affiliation":[{"name":"Liaoning University of Traditional Chinese Medicine  Shenyang China"},{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenping","family":"Wang","sequence":"additional","affiliation":[{"name":"Liaoning Cancer Hospital  Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaobin","family":"Li","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huawei","family":"Wang","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyan","family":"Dou","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Yu","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiujun","family":"Wu","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ran","family":"Ma","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caixia","family":"Jiang","sequence":"additional","affiliation":[{"name":"Hangzhou Bangshun Pharmaceutical Co., Ltd.  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Yu","sequence":"additional","affiliation":[{"name":"Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,30]]},"reference":[{"issue":"19","key":"e_1_2_10_2_1","first-page":"2752","article-title":"Clinical significance of uric acid crystals in patients with uric acid nephropathy treated with febuxostat","volume":"39","author":"Xin JD","year":"2023","journal-title":"Chin J Clin Pharmacol"},{"issue":"5","key":"e_1_2_10_3_1","first-page":"539","article-title":"Efficacy observation and influencing factors analysis of different doses of febuxostat in the treatment of gout with hyperuricemia","volume":"23","author":"Li ZG","year":"2023","journal-title":"Chin J Hosp Drug Eval Anal"},{"issue":"5","key":"e_1_2_10_4_1","first-page":"34","article-title":"Efficacy of febuxostat tablets in the treatment of gout with hyperuricemia","volume":"32","author":"Qin CM","year":"2024","journal-title":"Clin Res"},{"issue":"27","key":"e_1_2_10_5_1","first-page":"148","article-title":"Study on the efficacy and safety of febuxostat in patients with gout and hyperuricemia","volume":"8","author":"Wang TT","year":"2022","journal-title":"Smart Healthcare"},{"key":"e_1_2_10_6_1","volume-title":"Technical Guideline for Human Bioequivalence Studies of Chemical Generic Drugs with Pharmacokinetic Parameters as Endpoint Evaluation Indicators","author":"National Medical Products Administration of China","year":"2016"},{"issue":"6","key":"e_1_2_10_7_1","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1002\/art.40807","article-title":"Contemporary prevalence of gout and hyperuricemia in the United States and decadal trends: the National Health and Nutrition Examination Survey, 2007\u20132016","volume":"71","author":"Chen\u2010Xu M","year":"2019","journal-title":"Arthritis Rheumatol"},{"issue":"1","key":"e_1_2_10_8_1","first-page":"1","article-title":"Guidelines for the diagnosis and treatment of hyperuricemia and gout in China (2019)","volume":"36","author":"Endocrinology Branch of Chinese Medical Association","year":"2020","journal-title":"Chin J Endocrinol Metab"},{"issue":"1","key":"e_1_2_10_9_1","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1186\/s12916-017-0890-9","article-title":"Impact of comorbidities on gout and hyperuricaemia: an update on prevalence and treatment options","volume":"15","author":"Bardin T","year":"2017","journal-title":"BMC Med"},{"issue":"12","key":"e_1_2_10_10_1","first-page":"1896","article-title":"Bioequivalence of two febuxostat formulations in healthy Korean subjects under fasting and fed conditions","volume":"46","author":"Kim SH","year":"2020","journal-title":"Drug Dev Ind Pharm"},{"issue":"8","key":"e_1_2_10_11_1","first-page":"601","article-title":"Pharmacokinetics and bioequivalence of two febuxostat 40 mg tablet formulations in healthy Chinese male volunteers","volume":"5","author":"Li J","year":"2016","journal-title":"Clin Pharmacol Drug Dev"},{"issue":"5","key":"e_1_2_10_12_1","first-page":"689","article-title":"Effect of food on the pharmacokinetics of febuxostat in healthy Chinese subjects","volume":"12","author":"Yu X","year":"2023","journal-title":"Clin Pharmacol Drug Dev"},{"issue":"13","key":"e_1_2_10_13_1","first-page":"1488","article-title":"Research progress on matrix effect in determination of human plasma drug concentration by LC\u2010MS\/MS","volume":"24","author":"Feng XJ","year":"2015","journal-title":"Chin J New Drugs"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70104","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70104","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70104","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T04:54:53Z","timestamp":1790830493000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70104"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,30]]},"references-count":12,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/cpdd.70104"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70104","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,30]]},"assertion":[{"value":"2026-04-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70104"}}