Tramadol/Diclofenac Fixed‐Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product
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 mg)/diclofenac sodium (50 mg) fixed‐dose combination formulations under fed con...
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| Veröffentlicht in: | Clinical pharmacology in drug development 2024-08, Vol.13 (8), p.907-914 |
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| creator | da Silva, Thalita Martins Davanço, Marcelo Gomes Meulman, Jessica Vianna, Débora Renz Barreto Costa, Fernando Pacheco, Fernando Bastos Canton Carandina, Silvana Aparecida Calafatti Issa, Eduardo Vespasiano, Celso Francisco Pimentel |
| description | 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 mg)/diclofenac sodium (50 mg) fixed‐dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open‐label, randomized, single‐dose, 2‐period, 2‐way 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‐dose combination tablets with a 7‐day washout period. Blood samples were collected up to 36 hours after dosing for tramadol and 12 hours for diclofenac and quantified using a validated liquid chromatography‐tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration‐time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%‐125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice. |
| doi_str_mv | 10.1002/cpdd.1410 |
| format | Article |
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This study assessed the bioavailability and tolerability of 2 tramadol hydrochloride (50 mg)/diclofenac sodium (50 mg) fixed‐dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open‐label, randomized, single‐dose, 2‐period, 2‐way 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‐dose combination tablets with a 7‐day washout period. Blood samples were collected up to 36 hours after dosing for tramadol and 12 hours for diclofenac and quantified using a validated liquid chromatography‐tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration‐time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%‐125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice.</description><identifier>ISSN: 2160-763X</identifier><identifier>ISSN: 2160-7648</identifier><identifier>EISSN: 2160-7648</identifier><identifier>DOI: 10.1002/cpdd.1410</identifier><identifier>PMID: 38716761</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>acute pain ; Acute Pain - drug therapy ; Adult ; analgesia ; Analgesics, Opioid - administration & dosage ; Analgesics, Opioid - pharmacokinetics ; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics ; anti‐inflammatory ; Area Under Curve ; Bioavailability ; Biological Availability ; Brazil ; Cross-Over Studies ; diclofenac ; Diclofenac - administration & dosage ; Diclofenac - pharmacokinetics ; Drug Combinations ; Drugs, Generic - administration & dosage ; Drugs, Generic - adverse effects ; Drugs, Generic - pharmacokinetics ; Female ; Generic products ; Healthy Volunteers ; Humans ; Male ; Middle Aged ; Nonsteroidal anti-inflammatory drugs ; pain management ; Pain Management - methods ; pharmacokinetics ; Tandem Mass Spectrometry ; Therapeutic Equivalency ; tramadol ; Tramadol - administration & dosage ; Tramadol - pharmacokinetics ; Young Adult</subject><ispartof>Clinical pharmacology in drug development, 2024-08, Vol.13 (8), p.907-914</ispartof><rights>2024 The Authors. published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.</rights><rights>2024 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). 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Davanço, Marcelo Gomes ; Meulman, Jessica ; Vianna, Débora Renz Barreto ; Costa, Fernando ; Pacheco, Fernando Bastos Canton ; Carandina, Silvana Aparecida Calafatti ; Issa, Eduardo ; Vespasiano, Celso Francisco Pimentel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3480-93d3ee2a49fe3ee8f0cd41ca4d45ba0d39efc80e67a03d2c08f3735b6239d3953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>acute pain</topic><topic>Acute Pain - drug therapy</topic><topic>Adult</topic><topic>analgesia</topic><topic>Analgesics, Opioid - administration & dosage</topic><topic>Analgesics, Opioid - pharmacokinetics</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics</topic><topic>anti‐inflammatory</topic><topic>Area Under Curve</topic><topic>Bioavailability</topic><topic>Biological Availability</topic><topic>Brazil</topic><topic>Cross-Over Studies</topic><topic>diclofenac</topic><topic>Diclofenac - administration & dosage</topic><topic>Diclofenac - pharmacokinetics</topic><topic>Drug Combinations</topic><topic>Drugs, Generic - administration & dosage</topic><topic>Drugs, Generic - adverse effects</topic><topic>Drugs, Generic - pharmacokinetics</topic><topic>Female</topic><topic>Generic products</topic><topic>Healthy Volunteers</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>pain management</topic><topic>Pain Management - methods</topic><topic>pharmacokinetics</topic><topic>Tandem Mass Spectrometry</topic><topic>Therapeutic Equivalency</topic><topic>tramadol</topic><topic>Tramadol - administration & dosage</topic><topic>Tramadol - pharmacokinetics</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>da Silva, Thalita Martins</creatorcontrib><creatorcontrib>Davanço, Marcelo Gomes</creatorcontrib><creatorcontrib>Meulman, Jessica</creatorcontrib><creatorcontrib>Vianna, Débora Renz Barreto</creatorcontrib><creatorcontrib>Costa, Fernando</creatorcontrib><creatorcontrib>Pacheco, Fernando Bastos Canton</creatorcontrib><creatorcontrib>Carandina, Silvana Aparecida Calafatti</creatorcontrib><creatorcontrib>Issa, Eduardo</creatorcontrib><creatorcontrib>Vespasiano, Celso Francisco Pimentel</creatorcontrib><collection>Wiley_OA刊</collection><collection>Wiley Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical pharmacology in drug development</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>da Silva, Thalita Martins</au><au>Davanço, Marcelo Gomes</au><au>Meulman, Jessica</au><au>Vianna, Débora Renz Barreto</au><au>Costa, Fernando</au><au>Pacheco, Fernando Bastos Canton</au><au>Carandina, Silvana Aparecida Calafatti</au><au>Issa, Eduardo</au><au>Vespasiano, Celso Francisco Pimentel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tramadol/Diclofenac Fixed‐Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product</atitle><jtitle>Clinical pharmacology in drug development</jtitle><addtitle>Clin Pharmacol Drug Dev</addtitle><date>2024-08</date><risdate>2024</risdate><volume>13</volume><issue>8</issue><spage>907</spage><epage>914</epage><pages>907-914</pages><issn>2160-763X</issn><issn>2160-7648</issn><eissn>2160-7648</eissn><abstract>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 mg)/diclofenac sodium (50 mg) fixed‐dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open‐label, randomized, single‐dose, 2‐period, 2‐way 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‐dose combination tablets with a 7‐day washout period. Blood samples were collected up to 36 hours after dosing for tramadol and 12 hours for diclofenac and quantified using a validated liquid chromatography‐tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration‐time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%‐125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>38716761</pmid><doi>10.1002/cpdd.1410</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | acute pain Acute Pain - drug therapy Adult analgesia Analgesics, Opioid - administration & dosage Analgesics, Opioid - pharmacokinetics Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics anti‐inflammatory Area Under Curve Bioavailability Biological Availability Brazil Cross-Over Studies diclofenac Diclofenac - administration & dosage Diclofenac - pharmacokinetics Drug Combinations Drugs, Generic - administration & dosage Drugs, Generic - adverse effects Drugs, Generic - pharmacokinetics Female Generic products Healthy Volunteers Humans Male Middle Aged Nonsteroidal anti-inflammatory drugs pain management Pain Management - methods pharmacokinetics Tandem Mass Spectrometry Therapeutic Equivalency tramadol Tramadol - administration & dosage Tramadol - pharmacokinetics Young Adult |
| title | Tramadol/Diclofenac Fixed‐Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product |
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