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Effects of Hepatic Impairment on the Pharmacokinetic Profile and Safety of Lobeglitazone

Authors
 Jungsin Park  ;  Choon Ok Kim  ;  Eun Sil Oh  ;  Jung Il Lee  ;  Ja Kyung Kim  ;  Sang Hoon Ahn  ;  Do Young Kim  ;  Seung Up Kim  ;  Beom Kyung Kim  ;  Yong Eun Chung  ;  Se-Mi Kim  ;  Min Soo Park 
Citation
 CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, Vol.11(5) : 576-584, 2022-05 
Journal Title
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
ISSN
 2160-763X 
Issue Date
2022-05
MeSH
Humans ; Hypoglycemic Agents / pharmacokinetics ; Liver Diseases* ; Pyrimidines / adverse effects ; Thiazolidinediones* / pharmacokinetics
Keywords
hepatic impairment ; lobeglitazone ; pharmacokinetics ; safety ; thiazolidinediones
Abstract
In this open-label, single-dose, parallel-group study, we compared the pharmacokinetic profile and safety of lobeglitazone, a thiazolidinedione acting as an agonist for peroxisome proliferator-activated receptors, in patients with hepatic impairment (HI) and healthy matched controls for age, sex, and body weight. After a single oral dose of lobeglitazone (0.5 mg), the lobeglitazone (parent drug) and M7 (major metabolite) plasma concentrations and pharmacokinetic parameters were analyzed and compared between the HI patient groups and healthy matched control groups. The geometric mean ratio (GMR; 90% confidence interval [CI]) for maximum concentration (Cmax ) and area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf ) of lobeglitazone was 1.06 (0.90-1.24) and 1.07 (0.82-1.40), respectively, for mild HI vs control A. The GMR (90%CI) of Cmax and AUCinf was 0.70 (0.56-0.88) and 1.00 (0.72-1.37), respectively, for moderate HI vs control B. For M7, the GMR (90%CI) of Cmax and AUCinf was 1.09 (0.75-1.57) and 1.18 (0.71-1.97), respectively, for mild HI vs control A and 1.50 (0.95-2.38) and 1.79 (1.06-3.04), respectively, for moderate HI vs control B. Notable adverse events or tolerability issues were not observed. Lobeglitazone may be safely used in patients with mild or moderate HI without dose adjustment.
Full Text
https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1045
DOI
10.1002/cpdd.1045
Appears in Collections:
6. Others (기타) > Dept. of Clinical Pharmacology (임상시험센터) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영)
Kim, Beom Kyung(김범경) ORCID logo https://orcid.org/0000-0002-5363-2496
Kim, Seung Up(김승업) ORCID logo https://orcid.org/0000-0002-9658-8050
Kim, Ja Kyung(김자경) ORCID logo https://orcid.org/0000-0001-5025-6846
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
Lee, Jung Il(이정일) ORCID logo https://orcid.org/0000-0002-0142-1398
Chung, Yong Eun(정용은) ORCID logo https://orcid.org/0000-0003-0811-9578
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/194471
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