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Effects of Hepatic Impairment on the Pharmacokinetic Profile and Safety of Lobeglitazone
DC Field | Value | Language |
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dc.contributor.author | 김도영 | - |
dc.contributor.author | 김범경 | - |
dc.contributor.author | 김승업 | - |
dc.contributor.author | 김자경 | - |
dc.contributor.author | 김춘옥 | - |
dc.contributor.author | 박민수 | - |
dc.contributor.author | 안상훈 | - |
dc.contributor.author | 이정일 | - |
dc.contributor.author | 정용은 | - |
dc.date.accessioned | 2023-06-02T00:50:30Z | - |
dc.date.available | 2023-06-02T00:50:30Z | - |
dc.date.issued | 2022-05 | - |
dc.identifier.issn | 2160-763X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/194471 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Wiley | - |
dc.relation.isPartOf | CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Hypoglycemic Agents / pharmacokinetics | - |
dc.subject.MESH | Liver Diseases* | - |
dc.subject.MESH | Pyrimidines / adverse effects | - |
dc.subject.MESH | Thiazolidinediones* / pharmacokinetics | - |
dc.title | Effects of Hepatic Impairment on the Pharmacokinetic Profile and Safety of Lobeglitazone | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Jungsin Park | - |
dc.contributor.googleauthor | Choon Ok Kim | - |
dc.contributor.googleauthor | Eun Sil Oh | - |
dc.contributor.googleauthor | Jung Il Lee | - |
dc.contributor.googleauthor | Ja Kyung Kim | - |
dc.contributor.googleauthor | Sang Hoon Ahn | - |
dc.contributor.googleauthor | Do Young Kim | - |
dc.contributor.googleauthor | Seung Up Kim | - |
dc.contributor.googleauthor | Beom Kyung Kim | - |
dc.contributor.googleauthor | Yong Eun Chung | - |
dc.contributor.googleauthor | Se-Mi Kim | - |
dc.contributor.googleauthor | Min Soo Park | - |
dc.identifier.doi | 10.1002/cpdd.1045 | - |
dc.contributor.localId | A00385 | - |
dc.contributor.localId | A00487 | - |
dc.contributor.localId | A00654 | - |
dc.contributor.localId | A00852 | - |
dc.contributor.localId | A04735 | - |
dc.contributor.localId | A01468 | - |
dc.contributor.localId | A02226 | - |
dc.contributor.localId | A03122 | - |
dc.contributor.localId | A03662 | - |
dc.relation.journalcode | J04263 | - |
dc.identifier.eissn | 2160-7648 | - |
dc.identifier.pmid | 35255191 | - |
dc.identifier.url | https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1045 | - |
dc.subject.keyword | hepatic impairment | - |
dc.subject.keyword | lobeglitazone | - |
dc.subject.keyword | pharmacokinetics | - |
dc.subject.keyword | safety | - |
dc.subject.keyword | thiazolidinediones | - |
dc.contributor.alternativeName | Kim, Do Young | - |
dc.contributor.affiliatedAuthor | 김도영 | - |
dc.contributor.affiliatedAuthor | 김범경 | - |
dc.contributor.affiliatedAuthor | 김승업 | - |
dc.contributor.affiliatedAuthor | 김자경 | - |
dc.contributor.affiliatedAuthor | 김춘옥 | - |
dc.contributor.affiliatedAuthor | 박민수 | - |
dc.contributor.affiliatedAuthor | 안상훈 | - |
dc.contributor.affiliatedAuthor | 이정일 | - |
dc.contributor.affiliatedAuthor | 정용은 | - |
dc.citation.volume | 11 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 576 | - |
dc.citation.endPage | 584 | - |
dc.identifier.bibliographicCitation | CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, Vol.11(5) : 576-584, 2022-05 | - |
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