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Pharmacokinetics of a telmisartan/rosuvastatin fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects

Authors
 Dong Woo Chae  ;  Mijeong Son  ;  Yukyung Kim  ;  Hankil Son  ;  Seong Bok Jang  ;  Jeong Min Seo  ;  Su Youn Nam  ;  Kyungsoo Park 
Citation
 International Journal of Clinical Pharmacology and Therapeutics, Vol.53(10) : 883-889, 2015 
Journal Title
 International Journal of Clinical Pharmacology and Therapeutics 
ISSN
 0946-1965 
Issue Date
2015
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.
Full Text
http://www.dustri.com/nc/article-response-page.html?artId=13711&doi=
DOI
10.5414/CP202412
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실)
Yonsei Authors
김유경(Kim, Yu Kyung)
박경수(Park, Kyungsoo) ORCID logo https://orcid.org/0000-0002-6972-1143
손미정(Son, Mi Jeong)
채동우(Chae, Dong Woo) ORCID logo https://orcid.org/0000-0002-7675-3821
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/141707
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