Bioequivalence study of two Ibuprofen formulations administered intravenously in healthy male volunteers

To compare the systemic bioavailability of two ibuprofen formulations, Pedea((R)) (ibuprofen intravenous [IV] formulation) and Imbun((R)) (ibuprofen intramuscular [IM] formulation) in 18 healthy male volunteers. Each subject received a 5 mg/kg dose of ibuprofen base as a short 15-minute IV infusion...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Clinical drug investigation 2004-01, Vol.24 (12), p.739-747
Hauptverfasser: Chassard, D, Geneteau, A, Gualano, V, Brault, M
Format: Artikel
Sprache:eng
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 747
container_issue 12
container_start_page 739
container_title Clinical drug investigation
container_volume 24
creator Chassard, D
Geneteau, A
Gualano, V
Brault, M
description To compare the systemic bioavailability of two ibuprofen formulations, Pedea((R)) (ibuprofen intravenous [IV] formulation) and Imbun((R)) (ibuprofen intramuscular [IM] formulation) in 18 healthy male volunteers. Each subject received a 5 mg/kg dose of ibuprofen base as a short 15-minute IV infusion as the Pedea((R)) ibuprofen IV formulation or as the reference Imbun((R)) IM formulation. Concentrations of R- and S-ibuprofen were measured by a validated HPLC method with a lower limit of quantification of 0.100 microg/mL. A single 5 mg/kg injection of Pedea((R)) was well tolerated. The most frequent adverse event was a mild to moderate burning sensation along the injection vein probably related to the study treatments.The maximum serum concentration (C(max)) of R- and S-ibuprofen ranged from 20 to 35 microg/mL with both formulations. No statistical differences were observed for either C(max) or area under the plasma concentration-time curve (AUC). 90% CIs calculated for C(max) and AUC from time zero to infinity (AUC(infinity)) of R-ibuprofen and S-ibuprofen were included in the bioequivalence range 0.80-1.25. Based on AUC(infinity), the mean (SD) relative bioavailability of Pedea((R)) (ibuprofen IV formulation) versus the Imbun((R)) IM reference formulation was 1.06 (0.17) for R-ibuprofen and 1.05 (0.08) for S-ibuprofen. This study showed that Pedea((R)) (test formulation) is bioequivalent to Imbun((R)) IM (reference formulation) for both R-ibuprofen and S-ibuprofen. The Imbun((R)) IM formulation (lyophilisate) could be replaced by the Pedea((R)) ready-to-use IV solution. Moreover, these results allow a comparison of safety and efficacy data previously generated with either formulation. Consequently, neonatologists, who previously used the IM formulation intravenously for the treatment of patent ductus arteriosus in preterm infants, will now be able to administer the new ready-to-use IV solution of ibuprofen directly.
doi_str_mv 10.2165/00044011-200424120-00005
format Article
fullrecord <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_734208584</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A199858501</galeid><sourcerecordid>A199858501</sourcerecordid><originalsourceid>FETCH-LOGICAL-c381t-14b78155f1c5d1c2c3f7ad5c6e805083be795bd71ad23681153520ea316ebef73</originalsourceid><addsrcrecordid>eNptkcFvFSEQxjlo2lr7LxgSD562ZWBZ9h1ro22TJl70TFgYfJhdaIF95v33pb6nxsTMgZnJ75t85COEArvkMMgrxljfM4COt4b3wFnXVky-ImcASnRcDuKUvCnlB2MwwMBPyCkoyYUS6oxsP4aET2vYmRmjRVrq6vY0eVp_Jno_rY85eYzUp7yss6khxUKNW0IMpWJGR0Os2ewwprXM-zbRLZq5bvd0aRfpLs1rrIi5vCWvvZkLXhzfc_Lt86evN3fdw5fb-5vrh86KEWoH_aRGkNKDlQ4st8Ir46QdcGSSjWJCtZGTU2AcF8MIIIXkDI2AASf0SpyTD4e7zfnTiqXqJRSL82wiNo9aiZ6zUY59I98fyO_NqQ7Rp_YT-0Lra9hsGiMZNOryP1Qrh0uwKaIPbf-PYDwIbE6lZPT6MYfF5L0Gpl8S078T038S078Sa9J3R-_rtKD7KzzGJZ4Biv2T0w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>734208584</pqid></control><display><type>article</type><title>Bioequivalence study of two Ibuprofen formulations administered intravenously in healthy male volunteers</title><source>Springer Nature - Complete Springer Journals</source><creator>Chassard, D ; Geneteau, A ; Gualano, V ; Brault, M</creator><creatorcontrib>Chassard, D ; Geneteau, A ; Gualano, V ; Brault, M</creatorcontrib><description>To compare the systemic bioavailability of two ibuprofen formulations, Pedea((R)) (ibuprofen intravenous [IV] formulation) and Imbun((R)) (ibuprofen intramuscular [IM] formulation) in 18 healthy male volunteers. Each subject received a 5 mg/kg dose of ibuprofen base as a short 15-minute IV infusion as the Pedea((R)) ibuprofen IV formulation or as the reference Imbun((R)) IM formulation. Concentrations of R- and S-ibuprofen were measured by a validated HPLC method with a lower limit of quantification of 0.100 microg/mL. A single 5 mg/kg injection of Pedea((R)) was well tolerated. The most frequent adverse event was a mild to moderate burning sensation along the injection vein probably related to the study treatments.The maximum serum concentration (C(max)) of R- and S-ibuprofen ranged from 20 to 35 microg/mL with both formulations. No statistical differences were observed for either C(max) or area under the plasma concentration-time curve (AUC). 90% CIs calculated for C(max) and AUC from time zero to infinity (AUC(infinity)) of R-ibuprofen and S-ibuprofen were included in the bioequivalence range 0.80-1.25. Based on AUC(infinity), the mean (SD) relative bioavailability of Pedea((R)) (ibuprofen IV formulation) versus the Imbun((R)) IM reference formulation was 1.06 (0.17) for R-ibuprofen and 1.05 (0.08) for S-ibuprofen. This study showed that Pedea((R)) (test formulation) is bioequivalent to Imbun((R)) IM (reference formulation) for both R-ibuprofen and S-ibuprofen. The Imbun((R)) IM formulation (lyophilisate) could be replaced by the Pedea((R)) ready-to-use IV solution. Moreover, these results allow a comparison of safety and efficacy data previously generated with either formulation. Consequently, neonatologists, who previously used the IM formulation intravenously for the treatment of patent ductus arteriosus in preterm infants, will now be able to administer the new ready-to-use IV solution of ibuprofen directly.</description><identifier>ISSN: 1173-2563</identifier><identifier>DOI: 10.2165/00044011-200424120-00005</identifier><identifier>PMID: 17523737</identifier><language>eng</language><publisher>New Zealand: Wolters Kluwer Health, Inc</publisher><ispartof>Clinical drug investigation, 2004-01, Vol.24 (12), p.739-747</ispartof><rights>COPYRIGHT 2004 Wolters Kluwer Health, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381t-14b78155f1c5d1c2c3f7ad5c6e805083be795bd71ad23681153520ea316ebef73</citedby><cites>FETCH-LOGICAL-c381t-14b78155f1c5d1c2c3f7ad5c6e805083be795bd71ad23681153520ea316ebef73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17523737$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chassard, D</creatorcontrib><creatorcontrib>Geneteau, A</creatorcontrib><creatorcontrib>Gualano, V</creatorcontrib><creatorcontrib>Brault, M</creatorcontrib><title>Bioequivalence study of two Ibuprofen formulations administered intravenously in healthy male volunteers</title><title>Clinical drug investigation</title><addtitle>Clin Drug Investig</addtitle><description>To compare the systemic bioavailability of two ibuprofen formulations, Pedea((R)) (ibuprofen intravenous [IV] formulation) and Imbun((R)) (ibuprofen intramuscular [IM] formulation) in 18 healthy male volunteers. Each subject received a 5 mg/kg dose of ibuprofen base as a short 15-minute IV infusion as the Pedea((R)) ibuprofen IV formulation or as the reference Imbun((R)) IM formulation. Concentrations of R- and S-ibuprofen were measured by a validated HPLC method with a lower limit of quantification of 0.100 microg/mL. A single 5 mg/kg injection of Pedea((R)) was well tolerated. The most frequent adverse event was a mild to moderate burning sensation along the injection vein probably related to the study treatments.The maximum serum concentration (C(max)) of R- and S-ibuprofen ranged from 20 to 35 microg/mL with both formulations. No statistical differences were observed for either C(max) or area under the plasma concentration-time curve (AUC). 90% CIs calculated for C(max) and AUC from time zero to infinity (AUC(infinity)) of R-ibuprofen and S-ibuprofen were included in the bioequivalence range 0.80-1.25. Based on AUC(infinity), the mean (SD) relative bioavailability of Pedea((R)) (ibuprofen IV formulation) versus the Imbun((R)) IM reference formulation was 1.06 (0.17) for R-ibuprofen and 1.05 (0.08) for S-ibuprofen. This study showed that Pedea((R)) (test formulation) is bioequivalent to Imbun((R)) IM (reference formulation) for both R-ibuprofen and S-ibuprofen. The Imbun((R)) IM formulation (lyophilisate) could be replaced by the Pedea((R)) ready-to-use IV solution. Moreover, these results allow a comparison of safety and efficacy data previously generated with either formulation. Consequently, neonatologists, who previously used the IM formulation intravenously for the treatment of patent ductus arteriosus in preterm infants, will now be able to administer the new ready-to-use IV solution of ibuprofen directly.</description><issn>1173-2563</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><recordid>eNptkcFvFSEQxjlo2lr7LxgSD562ZWBZ9h1ro22TJl70TFgYfJhdaIF95v33pb6nxsTMgZnJ75t85COEArvkMMgrxljfM4COt4b3wFnXVky-ImcASnRcDuKUvCnlB2MwwMBPyCkoyYUS6oxsP4aET2vYmRmjRVrq6vY0eVp_Jno_rY85eYzUp7yss6khxUKNW0IMpWJGR0Os2ewwprXM-zbRLZq5bvd0aRfpLs1rrIi5vCWvvZkLXhzfc_Lt86evN3fdw5fb-5vrh86KEWoH_aRGkNKDlQ4st8Ir46QdcGSSjWJCtZGTU2AcF8MIIIXkDI2AASf0SpyTD4e7zfnTiqXqJRSL82wiNo9aiZ6zUY59I98fyO_NqQ7Rp_YT-0Lra9hsGiMZNOryP1Qrh0uwKaIPbf-PYDwIbE6lZPT6MYfF5L0Gpl8S078T038S078Sa9J3R-_rtKD7KzzGJZ4Biv2T0w</recordid><startdate>20040101</startdate><enddate>20040101</enddate><creator>Chassard, D</creator><creator>Geneteau, A</creator><creator>Gualano, V</creator><creator>Brault, M</creator><general>Wolters Kluwer Health, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20040101</creationdate><title>Bioequivalence study of two Ibuprofen formulations administered intravenously in healthy male volunteers</title><author>Chassard, D ; Geneteau, A ; Gualano, V ; Brault, M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381t-14b78155f1c5d1c2c3f7ad5c6e805083be795bd71ad23681153520ea316ebef73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chassard, D</creatorcontrib><creatorcontrib>Geneteau, A</creatorcontrib><creatorcontrib>Gualano, V</creatorcontrib><creatorcontrib>Brault, M</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical drug investigation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chassard, D</au><au>Geneteau, A</au><au>Gualano, V</au><au>Brault, M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bioequivalence study of two Ibuprofen formulations administered intravenously in healthy male volunteers</atitle><jtitle>Clinical drug investigation</jtitle><addtitle>Clin Drug Investig</addtitle><date>2004-01-01</date><risdate>2004</risdate><volume>24</volume><issue>12</issue><spage>739</spage><epage>747</epage><pages>739-747</pages><issn>1173-2563</issn><abstract>To compare the systemic bioavailability of two ibuprofen formulations, Pedea((R)) (ibuprofen intravenous [IV] formulation) and Imbun((R)) (ibuprofen intramuscular [IM] formulation) in 18 healthy male volunteers. Each subject received a 5 mg/kg dose of ibuprofen base as a short 15-minute IV infusion as the Pedea((R)) ibuprofen IV formulation or as the reference Imbun((R)) IM formulation. Concentrations of R- and S-ibuprofen were measured by a validated HPLC method with a lower limit of quantification of 0.100 microg/mL. A single 5 mg/kg injection of Pedea((R)) was well tolerated. The most frequent adverse event was a mild to moderate burning sensation along the injection vein probably related to the study treatments.The maximum serum concentration (C(max)) of R- and S-ibuprofen ranged from 20 to 35 microg/mL with both formulations. No statistical differences were observed for either C(max) or area under the plasma concentration-time curve (AUC). 90% CIs calculated for C(max) and AUC from time zero to infinity (AUC(infinity)) of R-ibuprofen and S-ibuprofen were included in the bioequivalence range 0.80-1.25. Based on AUC(infinity), the mean (SD) relative bioavailability of Pedea((R)) (ibuprofen IV formulation) versus the Imbun((R)) IM reference formulation was 1.06 (0.17) for R-ibuprofen and 1.05 (0.08) for S-ibuprofen. This study showed that Pedea((R)) (test formulation) is bioequivalent to Imbun((R)) IM (reference formulation) for both R-ibuprofen and S-ibuprofen. The Imbun((R)) IM formulation (lyophilisate) could be replaced by the Pedea((R)) ready-to-use IV solution. Moreover, these results allow a comparison of safety and efficacy data previously generated with either formulation. Consequently, neonatologists, who previously used the IM formulation intravenously for the treatment of patent ductus arteriosus in preterm infants, will now be able to administer the new ready-to-use IV solution of ibuprofen directly.</abstract><cop>New Zealand</cop><pub>Wolters Kluwer Health, Inc</pub><pmid>17523737</pmid><doi>10.2165/00044011-200424120-00005</doi><tpages>9</tpages></addata></record>
fulltext fulltext
identifier ISSN: 1173-2563
ispartof Clinical drug investigation, 2004-01, Vol.24 (12), p.739-747
issn 1173-2563
language eng
recordid cdi_proquest_miscellaneous_734208584
source Springer Nature - Complete Springer Journals
title Bioequivalence study of two Ibuprofen formulations administered intravenously in healthy male volunteers
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-24T11%3A45%3A09IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Bioequivalence%20study%20of%20two%20Ibuprofen%20formulations%20administered%20intravenously%20in%20healthy%20male%20volunteers&rft.jtitle=Clinical%20drug%20investigation&rft.au=Chassard,%20D&rft.date=2004-01-01&rft.volume=24&rft.issue=12&rft.spage=739&rft.epage=747&rft.pages=739-747&rft.issn=1173-2563&rft_id=info:doi/10.2165/00044011-200424120-00005&rft_dat=%3Cgale_proqu%3EA199858501%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=734208584&rft_id=info:pmid/17523737&rft_galeid=A199858501&rfr_iscdi=true