{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T14:33:40Z","timestamp":1774362820264,"version":"3.50.1"},"reference-count":22,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"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":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Repaglinide, an insulin secretagogue that predominantly lowers postprandial glucose, is approved for patients with type 2 diabetes inadequately controlled by diet, weight loss, and exercise. This study used a single\u2010center, randomized, open\u2010label, two\u2010formulation, single\u2010dose, four\u2010period, fully replicated, crossover design to evaluate the pharmacokinetics, bioequivalence, and safety of generic repaglinide tablets (1\u00a0mg) versus the innovator product in healthy Chinese subjects under fasting and fed conditions. Blood samples were assayed by validated liquid chromatography\u2010tandem mass spectrometry. After natural logarithmic transformation of pharmacokinetic parameters (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                    ), the bioequivalence of the test formulation and the reference formulation was evaluated using two one\u2010sided t\u2010tests and the 90% confidence intervals (CIs) method. The least\u2010squares geometric mean ratios (test\/reference) and 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                    all fell within the conventional bioequivalence ranges of 0.80\u20131.25. Both formulations were well tolerated, with no serious adverse events reported, and the food effect on repaglinide pharmacokinetics is further discussed. In summary, test and reference repaglinide tablets are bioequivalent and demonstrate similar pharmacokinetic characteristics and safety in healthy Chinese volunteers under both fasting and fed states.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70044","type":"journal-article","created":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T17:13:12Z","timestamp":1772989992000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and Bioequivalence Evaluation of Two Repaglinide Tablets Under Fasting and Fed Conditions in Healthy Chinese Volunteers"],"prefix":"10.1002","volume":"15","author":[{"given":"Biao","family":"Sun","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fangliang","family":"Gan","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Unit, Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiong","family":"Zhan","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Unit, Xianning Central Hospital The First Affiliated Hospital of Hubei University of Science and Technology  Xianning P. R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,27]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9136(199807)15:7<539::AID-DIA668>3.0.CO;2-S"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jare.2023.10.008"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1055\/a-2435-8264"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/diabetes.51.10.3107"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmet.2012.11.012"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31506-X"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1210\/endrev\/bnad030"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2024.06.029"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2017.03.024"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2165\/00129784-200707050-00002"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(00)88321-6"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002280100280"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270002239702"},{"issue":"4","key":"e_1_2_10_15_1","first-page":"S133","article-title":"Repaglinide as monotherapy in type 2 diabetes","volume":"107","author":"Gomis R","year":"1999","journal-title":"Exp Clin Endocrinol Diabetes"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1875-9114.1998.tb03137.x"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2005.02516.x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003253704"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9136(1998120)15:4 <S28::AID-DIA748>3.0.CO;2-T"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200241070-00002"},{"issue":"1","key":"e_1_2_10_21_1","first-page":"S43","article-title":"Repaglinide: prandial glucose regulation in clinical practice","volume":"2","author":"Owens DR","year":"2000","journal-title":"Diabetes Obes Metab"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ijo.0801422"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2013.08.001"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70044","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70044","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70044","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T13:48:40Z","timestamp":1774360120000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70044"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,27]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1002\/cpdd.70044"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70044","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,27]]},"assertion":[{"value":"2026-01-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70044"}}