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Influence of Hepatic Dysfunction on the Pharmacokinetics and Safety of Fimasartan

Authors
 Choon Ok Kim  ;  Hae Wan Lee  ;  Eun Sil Oh  ;  Sook Jin Seong  ;  Do Young Kim  ;  Joomi Lee  ;  Sang-Hoon Ahn  ;  Young-Ran Yoon  ;  Chang-Min Cho  ;  Min Soo Park 
Citation
 Journal of Cardiovascular Pharmacology, Vol.62(6) : 524-529, 2013 
Journal Title
 Journal of Cardiovascular Pharmacology 
ISSN
 0160-2446 
Issue Date
2013
Abstract
This study was designed to assess the pharmacokinetics (PK) and safety of fimasartan, an angiotensin II type 1 receptor blocker, in hepatic impairment patients as compared with healthy subjects. An open-label, single-dose, parallel study was conducted in 6 healthy male volunteers and 12 subjects with hepatic impairment. Healthy subjects were matched with hepatic dysfunction patients on the basis of age, gender, and body weight. After a single 120-mg oral administration of fimasartan, PK parameters and safety were analyzed between the hepatic dysfunction groups and healthy group. Compared with the healthy subjects, the geometric mean ratio and 90% confidence intervals for the maximum plasma concentration and the mean area under the plasma concentration-time curve from 0 to infinity (AUC)inf were 0.77 (0.24-2.47) and 1.11 (0.50-2.46), respectively, for the mild hepatic impairment and 6.55 (3.56-12.03) and 5.17 (4.19-6.37), respectively, for moderate hepatic impairment. However, there was no significant difference in time to peak plasma concentration (t(max)) and elimination half-life, and there were no serious or severe adverse events in all subjects. Subjects with mild hepatic impairment exhibited similar bioavailability compared with healthy subjects, whereas subjects with moderate hepatic impairment seemed to exhibit a higher level of systemic exposure to fimasartan than healthy subjects. In addition, all subjects were tolerable with fimasartan.
Full Text
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&AN=00005344-201312000-00004&LSLINK=80&D=ovft
DOI
10.1097/FJC.0000000000000010
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영)
Kim, Choon Ok(김춘옥) ORCID logo https://orcid.org/0000-0002-2319-1108
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/89251
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