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This single\u2010center, open\u2010label, sequence randomized, 2\u00a0\u00d7\u00a02 crossover, single\u2010dose clinical trial evaluated the pharmacokinetics profile and comparative bioavailability of a novel oral fixed\u2010dose combination (FDC) of metformin\/acetylsalicylic acid (500\/100\u00a0mg tablet) versus the reference mono\u2010drugs administered concomitantly, metformin 500\u00a0mg tablet and acetylsalicylic acid 100\u00a0mg tablet, in 22 healthy Mexican adult volunteers under fasting conditions. Blood samples were collected predose and at specified intervals across a 24\u2010hour period following administration and were analyzed for metformin and salicylic acid using high\u2010performance liquid chromatography coupled with tandem mass spectrometry. Test products were considered to have comparative bioavailability if confidence intervals of natural log\u2010transformed (maximum plasma drug concentration (C<jats:sub>max<\/jats:sub>), (area under the plasma drug concentration\u2010time curve form 0 up to last sampling time (AUC<jats:sub>0<\/jats:sub><jats:sub>\u2010t<\/jats:sub>), and (area under the plasma drug concentration\u2010time cruve from 0 up to infinity (AUC<jats:sub>0<\/jats:sub><jats:sub>\u221e<\/jats:sub>) data were within the range of 80%\u2010125%. The results obtained from the present clinical study demonstrate the comparative bioavailability of the FDC when compared with the coadministration of reference mono\u2010drugs. There were no adverse events or adverse reactions reported throughout the study.<\/jats:p>","DOI":"10.1002\/cpdd.1450","type":"journal-article","created":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T11:54:53Z","timestamp":1721649293000},"page":"1245-1252","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic Profile and Comparative Bioavailability of an Oral Fixed\u2010Dose Combination of Metformin and Acetylsalicylic Acid (Aspirin)"],"prefix":"10.1002","volume":"13","author":[{"given":"Lourdes","family":"Garza\u2010Oca\u00f1as","sequence":"first","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Le\u00f3n  Monterrey Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian T.","family":"Badillo\u2010Casta\u00f1eda","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Le\u00f3n  Monterrey Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra L.","family":"Montoya\u2010Egu\u00eda","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Le\u00f3n  Monterrey Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria T.","family":"Zanatta\u2010Calder\u00f3n","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Le\u00f3n  Monterrey Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pedro Lennon","family":"S\u00e1enz\u2010Ch\u00e1vez","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Le\u00f3n  Monterrey Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia D.","family":"Torres\u2010Garza","sequence":"additional","affiliation":[{"name":"Pharmacology and Toxicology Department Autonomous University of Nuevo Le\u00f3n  Monterrey Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ileana C.","family":"Rodriguez\u2010Vazquez","sequence":"additional","affiliation":[{"name":"Research and Development Department Laboratorios Silanes S.A. de C.V.  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Mexico City Mexico"},{"name":"Mexican Social Security Institute \u2013 Centro M\u00e9dico Nacional Siglo XXI  Mexico City Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,7,22]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.59.1.8"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/2047487319878371"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1213829"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-S010"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.4063"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2020.108008"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc08-9025"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1210\/endrev\/bnaa023"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-S009"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.2337\/db07-1098"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/db10-0351"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-06-858415"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.118.005418"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.116.025483"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-2356"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12872-022-02845-w"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-022-17327-4"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchf.2021.11.001"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz203"},{"issue":"4","key":"e_1_2_8_21_1","first-page":"363","article-title":"Treating prediabetes with metformin: systematic review and meta\u2010analysis","volume":"55","author":"Lily M","year":"2009","journal-title":"Can Fam Physician"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-021-01090-2"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.96.8.2751"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000677"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1061620"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.3346\/jkms.2011.26.6.765"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2007.03089.x"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchromb.2009.09.020"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.973"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.849"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-018-0853-3"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2014.09.003"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.703"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2013.05.015"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1450","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T04:25:48Z","timestamp":1730780748000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1450"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,22]]},"references-count":33,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1002\/cpdd.1450"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1450","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"type":"print","value":"2160-763X"},{"type":"electronic","value":"2160-7648"}],"subject":[],"published":{"date-parts":[[2024,7,22]]},"assertion":[{"value":"2024-05-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-13","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}