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Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan: A Randomized, Open-label, 3-period, Multiple-dose Crossover Study in Healthy Korean Male Subjects

DC FieldValueLanguage
dc.contributor.author노혜랑-
dc.contributor.author박경수-
dc.contributor.author손한길-
dc.contributor.author이동환-
dc.date.accessioned2015-01-06T17:15:44Z-
dc.date.available2015-01-06T17:15:44Z-
dc.date.issued2014-
dc.identifier.issn0149-2918-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/99644-
dc.description.abstractPURPOSE: Rosuvastatin has been widely used in combination with olmesartan for the treatment of dyslipidemia accompanied by hypertension. With no information currently available on the interaction between the 2 drugs, a pharmacokinetic study was conducted to investigate the influence of rosuvastatin on olmesartan and vice versa when the 2 drugs were coadministered. The purpose of this study was to investigate the pharmacokinetic profile of coadministration of the rosuvastatin 20-mg tablet and the olmesartan 40-mg tablet and the associated drug-drug interaction in healthy Korean male volunteers. METHODS: This was a randomized, open-label, 3-period, multiple-dose crossover study. Eligible subjects were aged 20 to 50 years and within 20% of their ideal body weight. After being randomly assigned to 6 groups of equal number, subjects received each of the following 3 formulations once a day for 7 consecutive days with an 8-day washout period between the formulations: rosuvastatin 20-mg tablet, olmesartan 40-mg tablet, and coadministration of the rosuvastatin 20-mg tablet and the olmesartan 40-mg tablet. Blood samples were collected up to 72 hours after dosing, and pharmacokinetic parameters were determined for rosuvastatin, its active metabolite (N-desmethyl rosuvastatin), and olmesartan. Adverse events were evaluated based on subject interviews and physical examinations. FINDINGS: Among the 36 enrolled subjects, 34 completed the study (mean [range] age, 28.6 [23-49] y; mean [range] weight, 66.4 [52.2-78.7] kg). The 90% CIs of the geometric mean ratios for the primary pharmacokinetic parameters for the coadministration of the 2 drugs to the mono-administration of each drug were 85.14% to 96.08% for AUCτ and 81.41% to 97.48% for Css,max for rosuvastatin, and 77.55% to 89.48% for AUCτ and 75.62% to 90.12% for Css,max for N-desmethyl rosuvastatin; those values were 95.61% to 102.57% for AUCτ and 91.73% to 102.98% for Css,max for olmesartan. Dizziness was the most frequently noted adverse drug reaction, occurring in 1 subject receiving mono-administration of rosuvastatin, 1 subject receiving mono-administration of olmesartan, and 4 subjects receiving coadministration of rosuvastatin and olmesartan. All the adverse events were expected, and there was no significant difference in the incidence between the 2 formulations. IMPLICATIONS: This study suggests that rosuvastatin and olmesartan did not significantly influence each other's pharmacokinetics when coadministered. Although the pharmacokinetics of N-desmethyl rosuvastatin were influenced by olmesartan, such interactions were considered clinically insignificant. All 3 formulations were well tolerated, and no serious adverse events or drug reactions were noted.-
dc.description.statementOfResponsibilityopen-
dc.format.extent1159~1170-
dc.relation.isPartOfClinical Therapeutics-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titlePharmacokinetic Interaction Between Rosuvastatin and Olmesartan: A Randomized, Open-label, 3-period, Multiple-dose Crossover Study in Healthy Korean Male Subjects-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Pharmacology (약리학)-
dc.contributor.googleauthorHyerang Roh-
dc.contributor.googleauthorHankil Son-
dc.contributor.googleauthorDonghwan Lee-
dc.contributor.googleauthorHeeChul Chang-
dc.contributor.googleauthorChohee Yun-
dc.contributor.googleauthorKyungsoo Park-
dc.identifier.doi10.1016/j.clinthera.2014.06.022-
dc.admin.authorfalse-
dc.admin.mappingfalse-
dc.contributor.localIdA01303-
dc.contributor.localIdA01422-
dc.contributor.localIdA01999-
dc.contributor.localIdA02740-
dc.relation.journalcodeJ00614-
dc.identifier.urlhttp://www.sciencedirect.com/science/article/pii/S0149291814003865-
dc.contributor.alternativeNameRoh, Hye Rang-
dc.contributor.alternativeNamePark, Kyung Soo-
dc.contributor.alternativeNameSon, Han kil-
dc.contributor.alternativeNameLee, Dong Hwan-
dc.contributor.affiliatedAuthorRoh, Hye Rang-
dc.contributor.affiliatedAuthorPark, Kyung Soo-
dc.contributor.affiliatedAuthorSon, Han kil-
dc.contributor.affiliatedAuthorLee, Dong Hwan-
dc.rights.accessRightsfree-
dc.citation.volume36-
dc.citation.number8-
dc.citation.startPage1159-
dc.citation.endPage1170-
dc.identifier.bibliographicCitationClinical Therapeutics, Vol.36(8) : 1159-1170, 2014-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers

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