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Comparison of Pharmacokinetics and Safety of a Fixed-dose Combination of Rosuvastatin and Ezetimibe Versus Separate Tablets in Healthy Subjects

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dc.contributor.author김춘옥-
dc.contributor.author박민수-
dc.date.accessioned2018-07-20T08:17:39Z-
dc.date.available2018-07-20T08:17:39Z-
dc.date.issued2017-
dc.identifier.issn0149-2918-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161054-
dc.description.abstractPURPOSE: Rosuvastatin and ezetimibe are concomitantly used for dyslipidemia treatment. Compared with separate tablets, fixed-dose combination (FDC) tablets of rosuvastatin/ezetimibe could increase patient compliance. The aim of this study was to compare the pharmacokinetic (PK) profiles of an FDC tablet of rosuvastatin/ezetimibe and co-administration of rosuvastatin and ezetimibe as separate tablets in healthy Korean volunteers. METHODS: This trial was a randomized, open-label, single-dose, 2-way crossover study. The healthy subjects received an FDC tablet of rosuvastatin 20 mg/ezetimibe 10 mg (test) or co-administration of rosuvastatin 20 mg and ezetimibe 10 mg (reference) in each period (periods 1 and 2), with a 14-day washout period. The blood samples for PK analysis were collected predose and up to 96 hours after administration, and safety was assessed throughout the study. FINDINGS: Sixty-four healthy Korean subjects were enrolled, and 57 subjects completed the study. All subjects were men and mean age was 28.52 ± 5.93. The geometric least squares mean ratios (test/reference) and 90% CIs of Cmax and AUC0-last were 101.54% (94.03-109.65) and 97.71% (91.86-103.93) for rosuvastatin, 108.93% (98.55-120.40) and 102.90% (96.72-109.47) for free ezetimibe, and 106.74% (98.18-116.05) and 104.24 % (99.53-109.17) for total ezetimibe. Twenty-four adverse events (AEs) were reported in 22 subjects. Three cases were related to the study drugs; 2 cases were mild, and 1 case was severe. However, all AEs were resolved without any sequelae. In addition, there were no serious AEs throughout the study. IMPLICATIONS: The FDC tablet of rosuvastatin/ezetimibe was well tolerated and resulted in comparable systemic exposure with co-administration of rosuvastatin and ezetimibe. ClinicalTrials.gov identifier: NCT02941848.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherExcerpta Medica-
dc.relation.isPartOfCLINICAL THERAPEUTICS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAnticholesteremic Agents/administration & dosage-
dc.subject.MESHAnticholesteremic Agents/adverse effects*-
dc.subject.MESHAnticholesteremic Agents/pharmacokinetics*-
dc.subject.MESHArea Under Curve-
dc.subject.MESHAsian Continental Ancestry Group-
dc.subject.MESHCross-Over Studies-
dc.subject.MESHDrug Combinations-
dc.subject.MESHEzetimibe/administration & dosage-
dc.subject.MESHEzetimibe/adverse effects*-
dc.subject.MESHEzetimibe/pharmacokinetics*-
dc.subject.MESHHealthy Volunteers-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHRosuvastatin Calcium/administration & dosage-
dc.subject.MESHRosuvastatin Calcium/adverse effects*-
dc.subject.MESHRosuvastatin Calcium/pharmacokinetics*-
dc.subject.MESHTablets-
dc.subject.MESHYoung Adult-
dc.titleComparison of Pharmacokinetics and Safety of a Fixed-dose Combination of Rosuvastatin and Ezetimibe Versus Separate Tablets in Healthy Subjects-
dc.typeArticle-
dc.contributor.collegeOthers-
dc.contributor.departmentSeverance Hospital-
dc.contributor.googleauthorKyoung Lok Min-
dc.contributor.googleauthorMin Soo Park-
dc.contributor.googleauthorJina Jung-
dc.contributor.googleauthorMin Jung Chang-
dc.contributor.googleauthorChoon Ok Kim-
dc.identifier.doi10.1016/j.clinthera.2017.07.038-
dc.contributor.localIdA04735-
dc.contributor.localIdA01468-
dc.relation.journalcodeJ00614-
dc.identifier.eissn1879-114X-
dc.identifier.pmid28803122-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0149291817308275-
dc.subject.keywordezetimibe-
dc.subject.keywordfixed-dose combination-
dc.subject.keywordpharmacokinetics-
dc.subject.keywordrosuvastatin-
dc.contributor.alternativeNameKim, Choon Ok-
dc.contributor.alternativeNamePark, Min Soo-
dc.contributor.affiliatedAuthorKim, Choon Ok-
dc.contributor.affiliatedAuthorPark, Min Soo-
dc.citation.volume39-
dc.citation.number9-
dc.citation.startPage1799-
dc.citation.endPage1810-
dc.identifier.bibliographicCitationCLINICAL THERAPEUTICS, Vol.39(9) : 1799-1810, 2017-
dc.identifier.rimsid60945-
dc.type.rimsART-
Appears in Collections:
6. Others (기타) > Dept. of Clinical Pharmacology (임상시험센터) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers

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