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Original Research

A pharmacokinetic and pharmacodynamic drug interaction between rosuvastatin and valsartan in healthy subjects

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Pages 745-752 | Published online: 02 Mar 2015

References

  • Diovan (valsartan) tablets [prescribing information]East Hanover, NJNovartis Pharmaceuticals Corporation2014 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021283s044lbl.pdfAccessed November 21, 2014
  • FleschGMüllerPLloydPAbsolute bioavailability and pharmacokinetics of valsartan, an angiotensin II receptor antagonist, in manEur J Clin Pharmacol19975221151209174680
  • SioufiAMarfilFJaouenAThe effect of age on the pharmacokinetics of valsartanBiopharm Drug Dispo1998194237244
  • McTaggartFBuckettLDavidsonRPreclinical and clinical pharmacology of Rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitorAm J Cardiol2001875A28B32B11137829
  • Crestor (rosuvastatin calcium) tablets [prescribing information]Wilmington, DEAstraZeneca Pharmaceuticals LP2013 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021366s030lbl.pdfAccessed November 21, 2014
  • MartinPDWarwickMJDaneALMetabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteersClin Ther200325112822283514693307
  • BirminghamBKSwanSKPuchalskiTPharmacokinetic and pharmacodynamic profile of rosuvastatin in patients with end-stage renal disease on chronic haemodialysisClin Drug Investig2013334233241
  • MartinPDMitchellPDSchneckDWPharmacodynamic effects and pharmacokinetics of a new HMG-CoA reductase inhibitor, rosuvastatin, after morning or evening administration in healthy volunteersBr J Clin Pharmacol200254547247712445025
  • MartinPDDaneALNwoseOMSchneckDWWarwickMJNo effect of age or gender on the pharmacokinetics of rosuvastatin: a new HMG-CoA reductase inhibitorJ Clin Pharmacol200242101116112112362926
  • YamashiroWMaedaKHirouchiMAdachiYHuZSugiyamaYInvolvement of transporters in the hepatic uptake and biliary excretion of valsartan, a selective antagonist of the angiotensin II AT1-receptor, in humansDrug Metab Dispos20063471247125416624871
  • HuaWJHuaWXFangHJThe role of OATP1B1 and BCRP in pharmacokinetics and DDI of novel statinsCardiovasc Ther2012305e234e24121884024
  • SonMKimYLeeDPharmacokinetic interaction between rosuvastatin and telmisartan in healthy Korean male volunteers: a randomized, open-label, two-period, crossover, multiple-dose studyClin Ther20143681147115824998012
  • World Medical Association (WMA)Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 7th revision64th WMA General AssemblyFortaleza, BrazilFerney-VoltaireWMA2013 Available from: www.wma.net/en/30publications/10policies/b3/Accessed December 12, 2014
  • SchmidtBSchiefferBAngiotensin II AT1 receptor antagonists. Clinical implications of active metabolitesJ Med Chem200346122261227012773029
  • NakashimaAKawashitaHMasudaNIdentification of cytochrome P450 forms involved in the 4-hydroxylation of valsartan, a potent and specific angiotensin II receptor antagonist, in human liver microsomesXenobiotica200535658960216192110
  • WaldmeierFFleschGMüllerPPharmacokinetics, disposition and biotransformation of [14C]-radiolabelled valsartan in healthy male volunteers after a single oral doseXenobiotica199727159719041679
  • LeeHKHoCSHuMTomlinsonBWongCKDevelopment and validation of a sensitive method for simultaneous determination of rosuvastatin and N-desmethyl rosuvastatin in human plasma using liquid chromatography/negative electrospray ionization/tandem mass spectrometryBiomed Chromatogr201327111369137423722358
  • Ministry of Food and Drug SafetyGuideline on Bioanalytical Method ValidationKoreaMinistry of Food and Drug Safety2013 Available from: https://eirb2.ajoumc.or.kr/board/file/Notice/Notice_1055.pdfAccessed January 13, 2015
  • IsrailiZHClinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertensionJ Hum Hypertens200014Suppl 1S73S8610854085
  • US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER)Guidance for Industry: drug interaction studies – study design, data analysis, implications for dosing, and labeling recommendations [draft guidance]Silver Spring, MDFDA CDER2012 Available at: http://www.fda.gov/downloads/drugs/guidance-complianceregulatoryinformation/guidances/ucm292362.pdfAccessed November 22, 2014
  • MüllerPFleschGde GasparoMGaspariniMHowaldHPharmacokinetics and pharmacodynamic effects of the angiotensin II antagonist valsartan at steady state in healthy, normotensive subjectsEur J Clin Pharmacol19975264414499342579
  • LeeERyanSBirminghamBRosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environmentClin Pharmacol Ther200578433034116198652
  • SunkaraGReynoldsCVPommierFHumbertHYehCPrasadPEvaluation of a pharmacokinetic interaction between valsartan and simvastatin in healthy subjectsCurr Med Res Opin200723363164017355744
  • MartinPDSchneckDWDaneALWarwickMJThe effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokineticsCurr Med Res Opin20082441231123518355422
  • CooperKJMartinPDDaneALWarwickMJRazaASchneckDWThe effect of erythromycin on the pharmacokinetics of rosuvastatinEur J Clin Pharmacol2003591515612682802
  • RohHSonHLeeDChangHYunCParkKPharmacokinetic interaction between rosuvastatin and olmesartan: a randomized, open-label, 3-period, multiple-dose crossover study in healthy Korean male subjectsClin Ther20143681159117025017182
  • JungJANohYHJinSPharmacokinetic interaction between pitavastatin and valsartan: a randomized, open-labeled crossover study in healthy male Korean volunteersClin Ther201234495896522410289
  • BellostaSPaolettiRCorsiniASafety of statins: focus on clinical pharmacokinetics and drug interactionsCirculation200410923 Suppl 1III50III5715198967