Comparisons of the pharmacokinetics and tolerability of fixed-dose combinations of amlodipine besylate/losartan and amlodipine camsylate/losartan in healthy subjects: a randomized, open-label, single-dose, two-period, two-sequence crossover study

References

• MesserliFHWilliamsBRitzEEssential hypertensionLancet2007370958759160317707755
   PubMed Web of Science ®Google Scholar
• JamesPAOparilSCarterBL2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8)JAMA2014311550752024352797
   PubMed Web of Science ®Google Scholar
• National Institute of Health and Clinical ExcellenceHypertension: Clinical Management of Primary Hypertension in AdultsLondonNICE2011NICE Clinical Guideline 127 Available from: https://www.nice.org.uk/guidance/cg127/resources/hypertension-in-adults-diagnosis-and-management-35109454941637Accessed January 25, 2016
   Google Scholar
• NeutelJMThe role of combination therapy in the management of hypertensionNephrol Dial Transplant20062161469147316714336
   PubMed Web of Science ®Google Scholar
• ChrysantSGUsing fixed-dose combination therapies to achieve blood pressure goalsClin Drug Investig20082811713734
   PubMed Web of Science ®Google Scholar
• AndreadisEATsourousGIMarakomichelakisGEHigh-dose monotherapy vs low-dose combination therapy of calcium channel blockers and angiotensin receptor blockers in mild to moderate hypertensionJ Hum Hypertens200519649149615759025
   PubMed Web of Science ®Google Scholar
• ErdineSCompliance with the treatment of hypertension: the potential of combination therapyJ Clin Hypertens20101214046
   Web of Science ®Google Scholar
• GuptaAKArshadSPoulterNRCompliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysisHypertension201055239940720026768
   PubMed Web of Science ®Google Scholar
• TonyENealHA.9 FDCs and multiple dosage strengthsPharmaceutical Lifecycle Management: Making the Most of Each and Every BrandHoboken, NJJohn Wilet & Sons, Inc2012
   Google Scholar
• JeffersBWRobbinsJBhambriRWajsbrotDA systematic review on the efficacy of amlodipine in the treatment of patients with hypertension with concomitant diabetes mellitus and/or renal dysfunction, when compared with other classes of antihypertensive medicationAm J Ther201522532234125738570
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration, Drugs@FDA [webpage on the Internet]Amlodipine Label Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdfAccessed January 25, 2016
   Google Scholar
• StepienOZhangYZhuDMarchePDual mechanism of action of amlodipine in human vascular smooth muscle cellsJ Hypertens20022019510211791031
   PubMed Web of Science ®Google Scholar
• SimpsonKLMcClellanKJLosartan: a review of its use, with special focus on elderly patientsDrugs Aging200016322725010803861
   PubMed Web of Science ®Google Scholar
• SicaDAGehrTWGhoshSClinical pharmacokinetics of losartanClin Pharmacokinet200544879781416029066
   PubMed Web of Science ®Google Scholar
• IsrailiZHClinical pharmacokinetics of angiotensin II (AT1) receptor blockers in hypertensionJ Hum Hypertens200014suppl 1S73S8610854085
   PubMed Web of Science ®Google Scholar
• WatanabeTBarkerTABerkBCAngiotensin II and the endothelium: diverse signals and effectsHypertension200545216316915630047
   PubMed Web of Science ®Google Scholar
• KangSMYounJCChaeSCComparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority studyClin Ther201133121953196322136978
   PubMed Web of Science ®Google Scholar
• Lawrence GouldAUnniachanSWuDIndirect treatment comparison between fixed-dose-combinations of amlodipine/losartan and amlodipine/valsartan in blood pressure controlInt J Clin Pract201468216317224460615
   PubMed Web of Science ®Google Scholar
• KimSWJunSSJoYGKooJ-SSun SO inventorHanall Pharmaceutical Co., assigneeCombined preparation for the cardiovascular diseases based on chronotherapy theoryU.S. Patent2010/0047341 A1252010
   Google Scholar
• KohlmannOJrOigmanWMionDJrThe “LOTHAR” study: evaluation of efficacy and tolerability of the fixed combination of amlodipine and losartan in the treatment of essential hypertensionArq Bras Cardiol2006861395116491208
   PubMedGoogle Scholar
• ParkCGYounHJChaeSCEvaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter studyAm J Cardiovasc Drugs2012121354722217192
   PubMed Web of Science ®Google Scholar
• KimSHRyuKHLeeNHEfficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter studyBMC Res Notes2011446122035131
   PubMedGoogle Scholar
• LeeSYKimJRJungJAHuhWBahngMYKoJWBioequivalence evaluation of two amlodipine salts, besylate and orotate, each in a fixed-dose combination with olmesartan in healthy subjectsDrug Des Devel Ther2015928112817
   PubMed Web of Science ®Google Scholar
• DavisonEWellsJIDinventorPfizer IncPharmaceutically, assigneeSalts of amlodipineEuropean patentEP 0244944 B11171989
   Google Scholar
• KimSHKimYDLimDSResults of a phase III, 8-week, multicenter, prospective, randomized, double-blind, parallel-group clinical trial to assess the effects of amlodipine camsylate versus amlodipine besylate in Korean adults with mild to moderate hypertensionClin Ther20072991924193618035192
   PubMed Web of Science ®Google Scholar
• KaralisVMacherasPExamining the role of metabolites in bioequivalence assessmentJ Pharm Pharm Sci201013219821720816006
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration, Center for Drug Evaluation and ResearchGuidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General ConsiderationsFood and Drug Administration, Center for Drug Evaluation and ResearchRockville2003
   Google Scholar
• European Medicines Agency (EMA)Committee for Medicinal Products for Human UseGuideline on the Investigation of BioequivalenceEMA, Committee for Medicinal Products for Human UseLondon2010
   Google Scholar
• US Food and Drug Administration [webpage on the Internet]Guidance on Losartan Potassium2008 Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm088645.pdfAccessed January 25, 2016
   Google Scholar
• MidhaKKRawsonMJHubbardJWThe role of metabolites in bioequivalencePharm Res20042181331134415359567
   PubMed Web of Science ®Google Scholar
• European Medicines Agency (EMA)Committee for Human Medicinal Products (CHMP) [webpage on the Internet]Questions & Answers: Positions on Specific Questions Addressed to the Pharmacokinetics Working Party (PKWP) Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002963.pdfAccessed January 25, 2016
   Google Scholar
• KorobokiEManiosEPsaltopoulouTCircadian variation of blood pressure and heart rate in normotensives, white-coat, masked, treated and untreated hypertensivesHellenic J Cardiol201253643243823178426
   PubMed Web of Science ®Google Scholar
• GrossmanEAmbulatory blood pressure monitoring in the diagnosis and management of hypertensionDiabetes Care201336suppl 2S307S31123882064
   PubMed Web of Science ®Google Scholar
• HigashiYNakagawaKKimuraMCircadian variation of blood pressure and endothelial function in patients with essential hypertension: a comparison of dippers and non-dippersJ Am Coll Cardiol200240112039204312475467
   PubMed Web of Science ®Google Scholar