Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects
Identifieur interne : 001397 ( Istex/Corpus ); précédent : 001396; suivant : 001398Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects
Auteurs : Robert J. Wills ; Nadia Choma ; Gerard Buonpane ; Amy Lin ; Nancy KeigherSource :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 1987-12.
English descriptors
- Teeft :
- Adverse experiences, Agents chemother, Bioavailability, Blood samples, Clinical consequence, Cmax, Corresponding values, Drug administration, Hayden, Healthy adults, Healthy subjects, Maximum concentration, Maximum concentrations, Oral solution, Pharmaceutical sciences, Pharmacokinetic, Pharmacokinetic parameters, Physical examination, Plasma concentration point, Plasma data, Present study, Randomized crossover design, Relative bioavailability, Rimantadine, Rimantadine plasma concentrations, Significant differences, Single dose, Single doses, Syrup, Tablet, Water washings.
Abstract
Twenty healthy male subjects completed an open‐label randomized crossover design to assess the bioavailability of 100 mg of rimantadine HCl in tablet and syrup forms relative to an oral solution. Blood samples were drawn and rimantadine plasma concentrations were determined by a GC‐MS method. The maximum plasma concentration (Cmax), the time to Cmax (tmax), the area under the plasma concentration—time curve (AUC), and k were compared among treatments using an analysis of variance and the Hauck—Anderson test for bioequivalence. The Hauck—Anderson test was satisfied when the syrup and solution were compared. The relative bioavailability of the syrup was 96%. Both Cmax and AUC were significantly (p < 0.05) increased (23 and 17%, respectively) when the tablet was compared with the solution. The relative bioavailability of the tablet was 117%. This outcome was unusual and could not be explained. However, this was not anticipated to be of clinical consequence since the majority of the safety and efficacy of rimantadine HCl was established using a tablet.
Url:
DOI: 10.1002/jps.2600761208
Links to Exploration step
ISTEX:554C716C13B5612C1532985F177597E4B1A40D81Le document en format XML
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Wills</name><affiliation><mods:affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</mods:affiliation></affiliation></author><author><name sortKey="Choma, Nadia" sort="Choma, Nadia" uniqKey="Choma N" first="Nadia" last="Choma">Nadia Choma</name><affiliation><mods:affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</mods:affiliation></affiliation></author><author><name sortKey="Buonpane, Gerard" sort="Buonpane, Gerard" uniqKey="Buonpane G" first="Gerard" last="Buonpane">Gerard Buonpane</name><affiliation><mods:affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</mods:affiliation></affiliation></author><author><name sortKey="Lin, Amy" sort="Lin, Amy" uniqKey="Lin A" first="Amy" last="Lin">Amy Lin</name><affiliation><mods:affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</mods:affiliation></affiliation></author><author><name sortKey="Keigher, Nancy" sort="Keigher, Nancy" uniqKey="Keigher N" first="Nancy" last="Keigher">Nancy Keigher</name><affiliation><mods:affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:554C716C13B5612C1532985F177597E4B1A40D81</idno><date when="1987" year="1987">1987</date><idno type="doi">10.1002/jps.2600761208</idno><idno type="url">https://api.istex.fr/ark:/67375/WNG-9XLV0RHN-G/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001397</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001397</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects</title><author><name sortKey="Wills, Robert J" sort="Wills, Robert J" uniqKey="Wills R" first="Robert J." last="Wills">Robert J. 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J.</forename><surname>Wills</surname></persName><affiliation><address><addrLine>Hoffmann‐La Roche</addrLine><addrLine>Inc.</addrLine><addrLine>Nutley</addrLine><addrLine>NJ 07110</addrLine><country key="US"></country></address></affiliation></author><author xml:id="author-0001"><persName><forename type="first">Nadia</forename><surname>Choma</surname></persName><affiliation><address><addrLine>Hoffmann‐La Roche</addrLine><addrLine>Inc.</addrLine><addrLine>Nutley</addrLine><addrLine>NJ 07110</addrLine><country key="US"></country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Gerard</forename><surname>Buonpane</surname></persName><affiliation><address><addrLine>Hoffmann‐La Roche</addrLine><addrLine>Inc.</addrLine><addrLine>Nutley</addrLine><addrLine>NJ 07110</addrLine><country key="US"></country></address></affiliation></author><author xml:id="author-0003"><persName><forename type="first">Amy</forename><surname>Lin</surname></persName><affiliation><address><addrLine>Hoffmann‐La Roche</addrLine><addrLine>Inc.</addrLine><addrLine>Nutley</addrLine><addrLine>NJ 07110</addrLine><country key="US"></country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">Nancy</forename><surname>Keigher</surname></persName><affiliation><address><addrLine>Hoffmann‐La Roche</addrLine><addrLine>Inc.</addrLine><addrLine>Nutley</addrLine><addrLine>NJ 07110</addrLine><country key="US"></country></address></affiliation></author><idno type="istex">554C716C13B5612C1532985F177597E4B1A40D81</idno><idno type="ark">ark:/67375/WNG-9XLV0RHN-G</idno><idno type="DOI">10.1002/jps.2600761208</idno><idno type="unit">JPS2600761208</idno><idno type="toTypesetVersion">file:JPS.JPS2600761208.pdf</idno></analytic><monogr><title level="j" type="main">Journal of Pharmaceutical Sciences</title><title level="j" type="alt">JOURNAL OF PHARMACEUTICAL SCIENCES</title><idno type="pISSN">0022-3549</idno><idno type="eISSN">1520-6017</idno><idno type="book-DOI">10.1002/(ISSN)1520-6017</idno><idno type="book-part-DOI">10.1002/jps.v76.12</idno><idno type="product">JPS</idno><imprint><biblScope unit="vol">76</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="886">886</biblScope><biblScope unit="page" to="888">888</biblScope><biblScope unit="page-count">3</biblScope><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Washington</pubPlace><date type="published" when="1987-12"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><abstract xml:lang="en" style="main"><head>Abstract</head><p>Twenty healthy male subjects completed an open‐label randomized crossover design to assess the bioavailability of 100 mg of rimantadine HCl in tablet and syrup forms relative to an oral solution. Blood samples were drawn and rimantadine plasma concentrations were determined by a GC‐MS method. The maximum plasma concentration (<hi rend="italic">C</hi><hi rend="subscript">max</hi>), the time to <hi rend="italic">C</hi><hi rend="subscript">max</hi> (<hi rend="italic">t</hi><hi rend="subscript">max</hi>), the area under the plasma concentration—time curve (AUC), and <hi rend="italic">k</hi> were compared among treatments using an analysis of variance and the Hauck—Anderson test for bioequivalence. The Hauck—Anderson test was satisfied when the syrup and solution were compared. The relative bioavailability of the syrup was 96%. Both <hi rend="italic">C</hi><hi rend="subscript">max</hi> and AUC were significantly (p < 0.05) increased (23 and 17%, respectively) when the tablet was compared with the solution. The relative bioavailability of the tablet was 117%. This outcome was unusual and could not be explained. However, this was not anticipated to be of clinical consequence since the majority of the safety and efficacy of rimantadine HCl was established using a tablet.</p></abstract><textClass><keywords rend="articleCategory"><term>Article</term></keywords><keywords rend="tocHeading1"><term>Articles</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-9XLV0RHN-G/fulltext.txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Washington</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1520-6017</doi><issn type="print">0022-3549</issn><issn type="electronic">1520-6017</issn><idGroup><id type="product" value="JPS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="JOURNAL OF PHARMACEUTICAL SCIENCES">Journal of Pharmaceutical Sciences</title><title type="short">J. 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Sci.</title></titleGroup></publicationMeta><publicationMeta level="part" position="120"><doi origin="wiley" registered="yes">10.1002/jps.v76.12</doi><numberingGroup><numbering type="journalVolume" number="76">76</numbering><numbering type="journalIssue">12</numbering></numberingGroup><coverDate startDate="1987-12">December 1987</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="8" status="forIssue"><doi origin="wiley" registered="yes">10.1002/jps.2600761208</doi><idGroup><id type="unit" value="JPS2600761208"></id></idGroup><countGroup><count type="pageTotal" number="3"></count></countGroup><titleGroup><title type="articleCategory">Article</title><title type="tocHeading1">Articles</title></titleGroup><copyright ownership="publisher">Copyright © 1987 Wiley‐Liss, Inc., A Wiley Company</copyright><eventGroup><event type="manuscriptReceived" date="1987-04-23"></event><event type="manuscriptAccepted" date="1987-07-30"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:3.2.6 mode:FullText" date="2013-11-18"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.2.6 mode:FullText" date="2013-11-18"></event><event type="firstOnline" date="2013-11-19"></event><event type="publishedOnlineFinalForm" date="2013-11-19"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-30"></event></eventGroup><numberingGroup><numbering type="pageFirst">886</numbering><numbering type="pageLast">888</numbering></numberingGroup><linkGroup><link type="toTypesetVersion" href="file:JPS.JPS2600761208.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="1"></count><count type="referenceTotal" number="16"></count></countGroup><titleGroup><title type="main" xml:lang="en">Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects</title><title type="short" xml:lang="en">Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Robert J.</givenNames><familyName>Wills</familyName></personName></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Nadia</givenNames><familyName>Choma</familyName></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Gerard</givenNames><familyName>Buonpane</familyName></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Amy</givenNames><familyName>Lin</familyName></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Nancy</givenNames><familyName>Keigher</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</unparsedAffiliation></affiliation></affiliationGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Twenty healthy male subjects completed an open‐label randomized crossover design to assess the bioavailability of 100 mg of rimantadine HCl in tablet and syrup forms relative to an oral solution. Blood samples were drawn and rimantadine plasma concentrations were determined by a GC‐MS method. The maximum plasma concentration (<i>C</i><sub>max</sub>), the time to <i>C</i><sub>max</sub> (<i>t</i><sub>max</sub>), the area under the plasma concentration—time curve (AUC), and <i>k</i> were compared among treatments using an analysis of variance and the Hauck—Anderson test for bioequivalence. The Hauck—Anderson test was satisfied when the syrup and solution were compared. The relative bioavailability of the syrup was 96%. Both <i>C</i><sub>max</sub> and AUC were significantly (p < 0.05) increased (23 and 17%, respectively) when the tablet was compared with the solution. The relative bioavailability of the tablet was 117%. This outcome was unusual and could not be explained. However, this was not anticipated to be of clinical consequence since the majority of the safety and efficacy of rimantadine HCl was established using a tablet.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Relative bioavailability of rimantadine HCI tablet and syrup formulations in healthy subjects</title></titleInfo><name type="personal"><namePart type="given">Robert J.</namePart><namePart type="family">Wills</namePart><affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nadia</namePart><namePart type="family">Choma</namePart><affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gerard</namePart><namePart type="family">Buonpane</namePart><affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Amy</namePart><namePart type="family">Lin</namePart><affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nancy</namePart><namePart type="family">Keigher</namePart><affiliation>Hoffmann‐La Roche, Inc., Nutley, NJ 07110</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Washington</placeTerm></place><dateIssued encoding="w3cdtf">1987-12</dateIssued><dateCaptured encoding="w3cdtf">1987-04-23</dateCaptured><dateValid encoding="w3cdtf">1987-07-30</dateValid><copyrightDate encoding="w3cdtf">1987</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">1</extent><extent unit="tables">1</extent><extent unit="references">16</extent></physicalDescription><abstract lang="en">Twenty healthy male subjects completed an open‐label randomized crossover design to assess the bioavailability of 100 mg of rimantadine HCl in tablet and syrup forms relative to an oral solution. Blood samples were drawn and rimantadine plasma concentrations were determined by a GC‐MS method. The maximum plasma concentration (Cmax), the time to Cmax (tmax), the area under the plasma concentration—time curve (AUC), and k were compared among treatments using an analysis of variance and the Hauck—Anderson test for bioequivalence. The Hauck—Anderson test was satisfied when the syrup and solution were compared. The relative bioavailability of the syrup was 96%. Both Cmax and AUC were significantly (p < 0.05) increased (23 and 17%, respectively) when the tablet was compared with the solution. The relative bioavailability of the tablet was 117%. This outcome was unusual and could not be explained. However, this was not anticipated to be of clinical consequence since the majority of the safety and efficacy of rimantadine HCl was established using a tablet.</abstract><relatedItem type="host"><titleInfo><title>Journal of Pharmaceutical Sciences</title></titleInfo><titleInfo type="abbreviated"><title>J. Pharm. Sci.</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>article-category</genre><topic>Article</topic></subject><identifier type="ISSN">0022-3549</identifier><identifier type="eISSN">1520-6017</identifier><identifier type="DOI">10.1002/(ISSN)1520-6017</identifier><identifier type="PublisherID">JPS</identifier><part><date>1987</date><detail type="volume"><caption>vol.</caption><number>76</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>886</start><end>888</end><total>3</total></extent></part></relatedItem><identifier type="istex">554C716C13B5612C1532985F177597E4B1A40D81</identifier><identifier type="ark">ark:/67375/WNG-9XLV0RHN-G</identifier><identifier type="DOI">10.1002/jps.2600761208</identifier><identifier type="ArticleID">JPS2600761208</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 1987 Wiley‐Liss, Inc., A Wiley Company</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-L0C46X92-X">wiley</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/ark:/67375/WNG-9XLV0RHN-G/record.json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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