Cited 11 times in
Pharmacokinetics of Rosuvastatin/Olmesartan Fixed-Dose Combination: A Single-Dose, Randomized, Open-Label, 2-Period Crossover Study in Healthy Korean Subjects
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 노혜랑 | - |
dc.contributor.author | 박경수 | - |
dc.contributor.author | 손한길 | - |
dc.contributor.author | 이동환 | - |
dc.date.accessioned | 2014-12-18T08:59:32Z | - |
dc.date.available | 2014-12-18T08:59:32Z | - |
dc.date.issued | 2013 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/87332 | - |
dc.description.abstract | BACKGROUND: Rosuvastatin, a lipid-lowering agent, has been widely used with olmesartan, a long-acting angiotensin II receptor blocker, indicated for the treatment of dyslipidemia accompanied by hypertension. A fixed-dose combination (FDC) tablet of these 2 drugs was recently developed to enhance the dosing convenience and to increase patient compliance while yielding pharmacokinetic profiles comparable to coadministration of each drug as individual tablets. OBJECTIVE: The goal of present study was to compare the pharmacokinetic profiles of single-dose administration of an FDC tablet containing rosuvastatin/olmesartan 20/40 mg (test formulation) with coadministration of a rosuvastatin 20-mg tablet and a olmesartan 40-mg tablet (reference formulation) in healthy Korean male volunteers, for the purpose of determining bioequivalence. METHODS: This single-dose, randomized, open-label, 2-period crossover study enrolled subjects aged 20 to 50 years and within 20% of ideal body weight. Each subject received a single dose of the test and reference formulations orally in a fasted state, with a 7-day washout period between the administrations. 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. Bioequivalence was concluded if the 90% CIs of the geometric mean ratios for the primary pharmacokinetic parameters were within the predetermined range of 80% to 125%. Adverse events (AEs) were evaluated based on subject interviews and physical examinations. RESULTS: Among the 58 enrolled subjects, 54 completed the study. The 90% CIs of the geometric mean ratios of the primary pharmacokinetic parameters were as follows: rosuvastatin: AUC(last), 85.60% to 97.40% and C(max), 83.16% to 98.21%; N-desmethyl rosuvastatin: AUC(last), 82.08% to 93.45% and C(max), 79.23% to 93.41%; and olmesartan: AUC(last), 97.69% to 105.69% and C(max), 100.35% to 109.42%. The most frequently noted AE was headache, occurring in 3 and 6 patients with the test and reference formulations, respectively. All of the AEs were expected, and there was no significant difference in the prevalences of AEs between the 2 formulations. CONCLUSIONS: The pharmacokinetic properties of the newly developed FDC tablet of rosuvastatin/olmesartan 20/40 mg suggest that it is bioequivalent to co-administration of each drug as individual tablets in these healthy Korean male subjects. The two formulations were well tolerated, with no serious AEs observed. ClinicalTrials.gov identifier: NCT01823900. | - |
dc.description.statementOfResponsibility | open | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Administration, Oral | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Drug Combinations | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Fluorobenzenes/administration & dosage* | - |
dc.subject.MESH | Fluorobenzenes/adverse effects | - |
dc.subject.MESH | Fluorobenzenes/pharmacokinetics* | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Imidazoles/administration & dosage* | - |
dc.subject.MESH | Imidazoles/adverse effects | - |
dc.subject.MESH | Imidazoles/pharmacokinetics* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Pyrimidines/administration & dosage* | - |
dc.subject.MESH | Pyrimidines/adverse effects | - |
dc.subject.MESH | Pyrimidines/pharmacokinetics* | - |
dc.subject.MESH | Rosuvastatin Calcium | - |
dc.subject.MESH | Sulfonamides/administration & dosage* | - |
dc.subject.MESH | Sulfonamides/adverse effects | - |
dc.subject.MESH | Sulfonamides/pharmacokinetics* | - |
dc.subject.MESH | Tetrazoles/administration & dosage* | - |
dc.subject.MESH | Tetrazoles/adverse effects | - |
dc.subject.MESH | Tetrazoles/pharmacokinetics* | - |
dc.subject.MESH | Young Adult | - |
dc.title | Pharmacokinetics of Rosuvastatin/Olmesartan Fixed-Dose Combination: A Single-Dose, Randomized, Open-Label, 2-Period Crossover Study in Healthy Korean Subjects | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pharmacology (약리학) | - |
dc.contributor.googleauthor | Hankil Son | - |
dc.contributor.googleauthor | Hyerang Roh | - |
dc.contributor.googleauthor | Donghwan Lee | - |
dc.contributor.googleauthor | HeeChul Chang | - |
dc.contributor.googleauthor | JunKu Kim | - |
dc.contributor.googleauthor | Chohee Yun | - |
dc.contributor.googleauthor | Kyungsoo Park | - |
dc.identifier.doi | 10.1016/j.clinthera.2013.05.016 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01303 | - |
dc.contributor.localId | A01422 | - |
dc.contributor.localId | A01999 | - |
dc.contributor.localId | A02740 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 23810276 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0149291813002683 | - |
dc.subject.keyword | combination drug | - |
dc.subject.keyword | dyslipidemia | - |
dc.subject.keyword | hypertension | - |
dc.subject.keyword | olmesartan | - |
dc.subject.keyword | pharmacokinetics | - |
dc.subject.keyword | rosuvastatin | - |
dc.contributor.alternativeName | Roh, Hye Rang | - |
dc.contributor.alternativeName | Park, Kyung Soo | - |
dc.contributor.alternativeName | Son, Han kil | - |
dc.contributor.alternativeName | Lee, Dong Hwan | - |
dc.contributor.affiliatedAuthor | Roh, Hye Rang | - |
dc.contributor.affiliatedAuthor | Park, Kyung Soo | - |
dc.contributor.affiliatedAuthor | Son, Han kil | - |
dc.contributor.affiliatedAuthor | Lee, Dong Hwan | - |
dc.rights.accessRights | not free | - |
dc.citation.volume | 35 | - |
dc.citation.number | 7 | - |
dc.citation.startPage | 915 | - |
dc.citation.endPage | 922 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.35(7) : 915-922, 2013 | - |
dc.identifier.rimsid | 32985 | - |
dc.type.rims | ART | - |
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