Cited 5 times in
Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects
DC Field | Value | Language |
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dc.contributor.author | 김유경 | - |
dc.contributor.author | 박경수 | - |
dc.contributor.author | 손미정 | - |
dc.contributor.author | 채동우 | - |
dc.date.accessioned | 2016-02-04T12:01:04Z | - |
dc.date.available | 2016-02-04T12:01:04Z | - |
dc.date.issued | 2015 | - |
dc.identifier.issn | 0946-1965 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/141707 | - |
dc.description.abstract | OBJECTIVE: As hypertension and dyslipidemia are frequent comorbidities, antihypertensive drugs and lipid-lowering agents are often prescribed together for their treatment. Telmisartan and rosuvastatin are widely used together to treat hypertension and dyslipidemia. A combination formulation of these two drugs would improve patient compliance due to ease of dosing. The purpose of this study was to assess bioequivalence of single-dose administration of a newly-developed fixed-dose combination (FDC) tablet containing telmisartan/rosuvastatin 80/20 mg (test treatment) and coadministration of a telmisartan 80-mg tablet and a rosuvastatin 20-mg tablet (reference treatment) in healthy Korean male volunteers. METHODS: This was a single-dose, randomized, open-label, 2-period crossover study enrolling healthy males aged 20 - 50 years with BMI between 18.5 and 25 kg/m2. Each subject received a single dose of the reference and test treatments with a 14-day washout period. Blood sampling was performed at prespecified intervals for up to 72 hours after dosing. Primary pharmacokinetic parameters were Cmax, AUClast, and AUC0-∞ of telmisartan, rosuvastatin, and N-desmethyl rosuvastatin. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) of the geometric mean ratios (test treatment/reference treatment) of these parameters were within the standard range of 80% to 125%. Adverse events were monitored via regular interviews with the subjects and by physical examinations. RESULTS: 60 subjects were enrolled and 55 completed the study. The 90% CIs of the geometric mean ratios of Cmax, AUClast, and AUC00-∞ were 0.9262-1.1498, 0.9294-1.0313, and 0.9312-1.0320 for telmisartan, 0.9041-1.0428, 0.9262-1.0085, and 0.9307-1.0094 for rosuvastatin, and 0.8718-1.0022, 0.8901-0.9904, and 0.8872-0.9767 for N-desmethyl rosuvastatin, respectively. There was no statistical difference in the incidence of adverse events (AEs) (all of which were mild or moderate) between the reference and test treatments. CONCLUSIONS: Our findings suggest that the telmisartan/rosuvastatin FDC is bioequivalent to coadministration of separate tablets, and both treatments were safe and well tolerated. Administration of this FDC tablet is expected to improve patient compliance. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 883~889 | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND 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 | Adult | - |
dc.subject.MESH | Benzimidazoles/administration & dosage | - |
dc.subject.MESH | Benzimidazoles/adverse effects | - |
dc.subject.MESH | Benzimidazoles/pharmacokinetics* | - |
dc.subject.MESH | Benzoates/administration & dosage | - |
dc.subject.MESH | Benzoates/adverse effects | - |
dc.subject.MESH | Benzoates/pharmacokinetics* | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Drug Combinations | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Rosuvastatin Calcium/administration & dosage | - |
dc.subject.MESH | Rosuvastatin Calcium/adverse effects | - |
dc.subject.MESH | Rosuvastatin Calcium/pharmacokinetics* | - |
dc.title | Pharmacokinetics of a telmisartan/rosuvastatin 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 | Dong Woo Chae | - |
dc.contributor.googleauthor | Mijeong Son | - |
dc.contributor.googleauthor | Yukyung Kim | - |
dc.contributor.googleauthor | Hankil Son | - |
dc.contributor.googleauthor | Seong Bok Jang | - |
dc.contributor.googleauthor | Jeong Min Seo | - |
dc.contributor.googleauthor | Su Youn Nam | - |
dc.contributor.googleauthor | Kyungsoo Park | - |
dc.identifier.doi | 10.5414/CP202412 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A00775 | - |
dc.contributor.localId | A01422 | - |
dc.contributor.localId | A01968 | - |
dc.contributor.localId | A04014 | - |
dc.relation.journalcode | J01098 | - |
dc.identifier.pmid | 26329347 | - |
dc.identifier.url | http://www.dustri.com/nc/article-response-page.html?artId=13711&doi= | - |
dc.subject.keyword | bioequivalence | - |
dc.subject.keyword | FDC | - |
dc.subject.keyword | pharmacokinetics | - |
dc.subject.keyword | rosuvastatin | - |
dc.subject.keyword | telmisartan | - |
dc.contributor.alternativeName | Kim, Yu Kyung | - |
dc.contributor.alternativeName | Park, Kyung Soo | - |
dc.contributor.alternativeName | Son, Mi Jeong | - |
dc.contributor.alternativeName | Chae, Dong Woo | - |
dc.contributor.affiliatedAuthor | Kim, Yu Kyung | - |
dc.contributor.affiliatedAuthor | Park, Kyung Soo | - |
dc.contributor.affiliatedAuthor | Son, Mi Jeong | - |
dc.contributor.affiliatedAuthor | Chae, Dong Woo | - |
dc.rights.accessRights | not free | - |
dc.citation.volume | 53 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 883 | - |
dc.citation.endPage | 889 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, Vol.53(10) : 883-889, 2015 | - |
dc.identifier.rimsid | 30831 | - |
dc.type.rims | ART | - |
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