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Pharmacokineticsofextendedreleaseandimmediatereleaseformulationsofgalantamineatsteadystateinhealthyvolunteers.PubMedNCBI

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Abstract
CurrMedResOpin.2005Oct21(10):154754.

Pharmacokineticsofextendedreleaseandimmediatereleaseformulations
ofgalantamineatsteadystateinhealthyvolunteers.
ZhaoQ1,JanssensL,VerhaegheT,BrashearHR,TruyenL.

Authorinformation
1

Johnson&JohnsonPharmaceuticalResearch&Development,L.L.C.,Titusville,NJ08560,USA.
qzhao@prdus.jnj.com

Erratumin
CurrMedResOpin.2006Feb22(2):441.

Abstract
OBJECTIVE: Toassessthesteadystategalantamine(GAL)bioavailabilityoftheextendedrelease
24mgqdcapsule(GALER)withandwithoutfoodandtoevaluatetherelativebioavailabilityofGAL
ERwiththeimmediaterelease12mgbidtablet(GALIR)atsteadystate.
METHODS: Thiswasasinglecenter,openlabel,randomized,3waycrossoverstudyin24healthy
volunteers(12malesand12females)aged18to45years.After7daysofGALER8mgqdeach
morningand7daysofGALER16mgqdeachmorning,subjectsreceivedthefollowingtreatments
inrandomized,crossoverorder(7dayseach):GALER24mgqdeachmorning(fastedbeforeDay
7morningdose),GALER24mgqdeachmorning(fedbeforeDay7morningdose),andGALIR12
mgbid(fastedbeforeDay7).PharmacokineticparametersofGALatsteadystateweredetermined
aftermorningintakeonDay7ofeachtreatmentweek.Safetyevaluationsincludedadverseevent
(AE)reporting,physicalexamination,clinicallaboratorytests,vitalsigns,andelectrocardiography.
RESULTS: ThetreatmentratiosofareaundertheplasmaconcentrationtimecurveofGALfrom
time024hpostdosing(AUC24h),peakplasmaconcentration(Cmax),andpredoseplasma
concentration(Cmin)forGALERfed/fastingwere105%,112%,and103%,respectively.The
treatmentratiosand90%confidenceintervalsforallabovementionedpharmacokineticparameters
demonstratedbioequivalence(withtherangeof80125%),indicatingthatfoodhadnoeffecton
GALERbioavailability.Asanticipated,GALER(fasting)hadmeanAUC24hsimilartoGALIR
(fasting),withlowerCmax(63ng/mLvs84ng/mL)andlongertimetoreachCmax(4.4hvs1.2h).
Thetreatmentratiosand90%confidenceintervalsforbothAUC24handCmindemonstrated
bioequivalence(withintherangeof80125%).ThetreatmentratioforCmaxwas75.7%,indicatinga
24%lowerCmaxforGALERthanforGALIR.Inthisstudy,GALERwassafeandwelltoleratedwith
orwithoutfoodandwascomparabletotheGALIRformulation.
https://www.ncbi.nlm.nih.gov/pubmed/16238894

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2/14/2016

Pharmacokineticsofextendedreleaseandimmediatereleaseformulationsofgalantamineatsteadystateinhealthyvolunteers.PubMedNCBI

CONCLUSION: FoodhadnoeffectontheGALbioavailabilityofGALERatsteadystate.GALER
wasbioequivalenttoGALIRwithrespecttoAUC24handCmin.
PMID:16238894[PubMedindexedforMEDLINE]

PublicationTypes,MeSHTerms,Substances
PublicationTypes
ComparativeStudy
RandomizedControlledTrial
ResearchSupport,NonU.S.Gov't
MeSHTerms
Adolescent
Adult
BiologicalAvailability
CrossOverStudies
DelayedActionPreparations
Female
Galantamine/administration&dosage*
Galantamine/pharmacokinetics*
Humans
Male
MiddleAged
Substances
DelayedActionPreparations
Galantamine

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Taylor&FrancisPDF
Miscellaneous
GALANTAMINEHazardousSubstancesDataBank

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Pharmacokineticsofextendedreleaseandimmediatereleaseformulationsofgalantamineatsteadystateinhealthyvolunteers.PubMedNCBI

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