{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T00:33:43Z","timestamp":1722558823050},"reference-count":22,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T00:00:00Z","timestamp":1715126400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The multimodal analgesia strategy for acute pain involves using 2 or more analgesic medications with distinct mechanisms of action. This study assessed the bioavailability and tolerability of 2 tramadol hydrochloride (50\u00a0mg)\/diclofenac sodium (50\u00a0mg) fixed\u2010dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open\u2010label, randomized, single\u2010dose, 2\u2010period, 2\u2010way crossover trial was conducted, including healthy subjects of both sexes. Subjects received a single dose of either the test or reference formulation of tramadol\/diclofenac fixed\u2010dose combination tablets with a 7\u2010day washout period. Blood samples were collected up to 36\u00a0hours after dosing for tramadol and 12\u00a0hours for diclofenac and quantified using a validated liquid chromatography\u2010tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration\u2010time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%\u2010125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice.<\/jats:p>","DOI":"10.1002\/cpdd.1410","type":"journal-article","created":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T10:18:06Z","timestamp":1715163486000},"page":"907-914","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Tramadol\/Diclofenac Fixed\u2010Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product"],"prefix":"10.1002","volume":"13","author":[{"given":"Thalita Martins","family":"da Silva","sequence":"first","affiliation":[{"name":"Clinical Research Unit Adium S.A.  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