{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:18:47Z","timestamp":1787663927923,"version":"build-2736575974"},"reference-count":17,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":16,"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"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81971172"],"award-info":[{"award-number":["81971172"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004731","name":"Natural Science Foundation of Zhejiang Province","doi-asserted-by":"publisher","award":["LR21H090001"],"award-info":[{"award-number":["LR21H090001"]}],"id":[{"id":"10.13039\/501100004731","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100022963","name":"Key Research and Development Program of Zhejiang Province","doi-asserted-by":"publisher","award":["WKJ\u2010ZJ\u20101914"],"award-info":[{"award-number":["WKJ\u2010ZJ\u20101914"]}],"id":[{"id":"10.13039\/100022963","id-type":"DOI","asserted-by":"publisher"}]}],"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                    To evaluate the bioequivalence and safety of a generic ibuprofen arginine formulation (T) compared to Sibide (R) in healthy Chinese subjects under fed conditions, a randomized, open\u2010label, single\u2010dose, two\u2010period, two\u2010sequence crossover study was conducted. Twenty\u2010eight eligible healthy subjects received a single 400\u00a0mg dose of either the T or R formulation following a standardized high\u2010fat meal, with a 3\u2010day washout period between doses. Plasma ibuprofen concentrations were quantified using a validated LC\u2010MS\/MS method. Pharmacokinetic parameters, including C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    , were calculated using non\u2010compartmental analysis. Bioequivalence was assessed based on the geometric mean ratios (GMRs) and 90% confidence intervals (CIs) derived from ANOVA. All 28 enrolled subjects completed the study. The GMRs (90% CIs) for C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2013t,<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    were 107.03% (100.02%\u2013114.52%), 100.99% (98.46%\u2013103.58%), and 100.95% (98.24%\u2013103.74%), respectively. All 90% CIs fell entirely within the regulatory bioequivalence acceptance range of 0.80\u20131.25. Both formulations were well tolerated; adverse events were mild to moderate, and no serious adverse events were reported. Thus, the T formulation of ibuprofen arginine demonstrated bioequivalence to the R formulation in healthy Chinese subjects under fed conditions.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70083","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T07:48:02Z","timestamp":1786952882000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence Study of Two Ibuprofen Arginine Formulations in Healthy Chinese Subjects Under Fed Conditions"],"prefix":"10.1002","volume":"15","author":[{"given":"Yiyang","family":"Ying","sequence":"first","affiliation":[{"name":"The First Clinical Medical College Zhejiang Chinese Medical University  Hangzhou Zhejiang Province China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunqi","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine The Second Affiliated Hospital of Zhejiang Chinese Medical University, Xinhua Hospital of Zhejiang Province  Hangzhou Zhejiang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Xu","sequence":"additional","affiliation":[{"name":"School of Pharmacy Hangzhou Normal University  Hangzhou Zhejiang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Wu","sequence":"additional","affiliation":[{"name":"Clinical Research Center Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"},{"name":"Zhejiang Key Laboratory of Zero Magnetic Medicine Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shufan","family":"Cai","sequence":"additional","affiliation":[{"name":"Clinical Research Center Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"},{"name":"Zhejiang Key Laboratory of Zero Magnetic Medicine Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lijun","family":"Ye","sequence":"additional","affiliation":[{"name":"Clinical Research Center Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"},{"name":"Zhejiang Key Laboratory of Zero Magnetic Medicine Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangxin","family":"Huang","sequence":"additional","affiliation":[{"name":"Clinical Research Center Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"},{"name":"Zhejiang Key Laboratory of Zero Magnetic Medicine Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Research Center Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"},{"name":"Zhejiang Key Laboratory of Zero Magnetic Medicine Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Research Center Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"},{"name":"Zhejiang Key Laboratory of Zero Magnetic Medicine Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,17]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10787-009-0016-x"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199834020-00002"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.2174\/157488410793352012"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-002-0491-0"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40122-025-00735-5"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S280571"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.16482"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2013.08.013"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.56759\/rgxl7405"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199937030-00003"},{"issue":"12","key":"e_1_2_10_12_1","first-page":"1158","article-title":"Effect of high\u2010fat diet intake on pharmacokinetics of oral ibuprofen granules in healthy Chinese volunteers","volume":"47","author":"Song H","year":"2020","journal-title":"J Int Pharm Res"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199834020-00002"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S404756"},{"issue":"1","key":"e_1_2_10_15_1","first-page":"107","article-title":"Bioequivalence of ibuprofen arginine granules in healthy Chinese volunteers","volume":"40","author":"Shi PP","year":"2024","journal-title":"Zhongguo Linchuang Yaolixue Zazhi"},{"key":"e_1_2_10_16_1","volume-title":"Guidance for Industry: Food\u2010Effect Bioavailability and Fed Bioequivalence Studies","author":"U.S. Food and Drug Administration","year":"2002"},{"key":"e_1_2_10_17_1","volume-title":"Ibuprofen Oral Use Immediate\u2010Release Formulations 200\u2013800\u00a0mg Product\u2010Specific Bioequivalence Guidance (Revision 1)","author":"European 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