{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:18:52Z","timestamp":1787663932213,"version":"build-2736575974"},"reference-count":20,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T00:00:00Z","timestamp":1787443200000},"content-version":"vor","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"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"}],"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                    This study evaluated the pharmacokinetic profiles and comparative bioavailability of etoricoxib 90 mg tablets and betamethasone 0.25 mg\/0.5 mL solution, administered individually (reference drugs), versus a fixed\u2010dose combination (FDC) tablet containing etoricoxib 90 mg and betamethasone 0.25 mg (test drug) under fasting conditions in healthy Mexican volunteers. A randomized, open\u2010label, three\u2010period, crossover, single\u2010dose study with a 14\u2010day washout period was conducted. Study drugs were administered orally following a 10\u2010h overnight fast with 250 mL of water and fasting continued for at least 4 h post\u2010dose. Serial blood samples were collected pre\u2010 and post\u2010dose, and the drug concentrations were quantified using Liquid Chromatography coupled to Tandem Mass Spectrometry (LC\u2010MS\/MS). Forty\u2010two subjects (22 women, 20 men; mean age 22.7 years; mean weight 64.7 kg) were enrolled, and 39 completed the study. Comparative bioavailability was established if the 90% confidence intervals of log\u2010transformed C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u201372 h<\/jats:sub>\n                    fell within the predefined range of 80%\u2013125%. Two non\u2010serious adverse events were reported. Results demonstrated that the pharmacokinetic profile and bioavailability of the etoricoxib\/betamethasone FDC were comparable to those of reference formulations, with no evidence of pharmacokinetic interactions.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70100","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T06:33:14Z","timestamp":1787553194000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Bioavailability of a Fixed\u2010Dose Combination of Etoricoxib and Betamethasone in Healthy Volunteers"],"prefix":"10.1002","volume":"15","author":[{"given":"Lourdes","family":"Garza\u2010Oca\u00f1as","sequence":"first","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Leon Monterrey Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian T.","family":"Badillo\u2010Casta\u00f1eda","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Leon Monterrey Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra L.","family":"Montoya\u2010Egu\u00eda","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Leon Monterrey Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda T.","family":"Zanatta\u2010Calder\u00f3n","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Leon Monterrey Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia D.","family":"Torres\u2010Garza","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Leon Monterrey Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro Lennon","family":"S\u00e1enz\u2010 Ch\u00e1vez","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Leon Monterrey Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin F.","family":"Rios\u2010Brito","sequence":"additional","affiliation":[{"name":"Research and Development Department Laboratorios Silanes, S.A. de C.V. Mexico City Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo E.","family":"Morales\u2010Hernandez","sequence":"additional","affiliation":[{"name":"Research and Development Department Laboratorios Silanes, S.A. de C.V. Mexico City Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seydhel C.","family":"Reyes\u2010Granados","sequence":"additional","affiliation":[{"name":"Research and Development Department Laboratorios Silanes, S.A. de C.V. Mexico City Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Gonz\u00e1lez\u2010Canudas","sequence":"additional","affiliation":[{"name":"Research and Development Department Laboratorios Silanes, S.A. de C.V. Mexico City Mexico"},{"name":"Mexican Social Security Institute (IMSS) Centro M\u00e9dico Nacional Siglo XXI  Mexico City Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,23]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.1.2.269"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2217\/17460816.2.6.545"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200847110-00002"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12724"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2005.09.018"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra050541"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keab503"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kex156"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41247"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2006.08.033"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1161\/HYPERTENSIONAHA.109.139816"},{"key":"e_1_2_9_13_1","first-page":"17","volume-title":"Diario Oficial de la Federaci\u00f3n","author":"NOM\u2010177\u2010SSA1\u20102013","year":"2013"},{"issue":"11","key":"e_1_2_9_14_1","first-page":"617","article-title":"Pharmacokinetic and bioequivalence study of etoricoxib tablet in healthy Bangladeshi volunteers","volume":"61","author":"Shohag MH","year":"2011","journal-title":"Arzneimittelforschung"},{"issue":"1","key":"e_1_2_9_15_1","first-page":"2","article-title":". Development and validation of a sensitive LC\u2010MS\/MS method for determination of betamethasone in human plasma: application to a pharmacokinetic study of healthy Mexican subjects","volume":"15","author":"Omar PR","year":"2019","journal-title":"Curr Pharm Anal"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2008.08.011"},{"key":"e_1_2_9_17_1","volume-title":"Phoenix WinNonlin, version 8.3","author":"Certara LP","year":"2020"},{"key":"e_1_2_9_18_1","first-page":"43","article-title":"Pharmacokinetic equivalence study of nonsteroidal anti\u2010inflammatory drug etoricoxib","volume":"10","author":"Tjandrawinata RR","year":"2018","journal-title":"Clin Pharmacol Adv Appl"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003251122"},{"key":"e_1_2_9_20_1","first-page":"1","article-title":"Bioequivalence study of two etoricoxib 90 mg film\u2010coated tablet formulations","volume":"6","author":"Suyatna FD","year":"2022","journal-title":"Bioequiv Bioavailab Int J"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics15112569"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70100","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70100","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70100","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T12:24:01Z","timestamp":1787660641000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70100"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":20,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1002\/cpdd.70100"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70100","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"2026-03-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70100"}}