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PEG-인터페론 알파-2a 제제 DA-3021의 안전성 및 약동력학적 특성 연구
DC Field | Value | Language |
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dc.contributor.author | 장성복 | - |
dc.contributor.author | 정재용 | - |
dc.contributor.author | 박경수 | - |
dc.contributor.author | 손한길 | - |
dc.contributor.author | 이동환 | - |
dc.contributor.author | 이윤정 | - |
dc.contributor.author | 임아영 | - |
dc.date.accessioned | 2015-04-23T17:47:41Z | - |
dc.date.available | 2015-04-23T17:47:41Z | - |
dc.date.issued | 2010 | - |
dc.identifier.issn | 1225-5467 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/103145 | - |
dc.description.abstract | Background: Interferons (IFNs) are proteins made and released by lymphocytes in response to the presence of pathogens and used in the treatment of hepatitis B or C virus. The purpose of this study is to investigate the safety, pharmacokinetics and pharmacodynamics of a pegylated interferon alpha-2a formulation. Methods: This study was a randomized, open-label, 2-period, crossover design. Each group had 17 subjects who took $180\;{\mu}g$ of $PEGASYS^®$ as a reference formulation and DA-3021 as a test formulation with a washout period of 21 days. Blood samples were obtained over 336 hours after the dose in each treatment period. Blood concentrations of interferon were analyzed using the enzyme-linked immunosorbent assay (ELISA). The primary pharmacokinetic parameters were Cmax and $AUC_{last}$. The pharmacodynamics were assessed by 2',5'-OAS (oligoadenylate synthetase) using a radioimmunoassay (RIA). The primary pharmacodynamic parameters were $E_{max}$ and $AUE_{last}$. Results: Thirty four healthy male volunteers participated in the study and completed both treatment periods. The 90% confidence intervals for the geometric mean ratios of the pharmacodynamic parameters (test : reference drug) were 0.95-1.09 for $AUE_{last}$ and 0.92-1.05 for $E_{max}$, lying within the bioequivalence range of 0.8-1.25, while the pharmacokinetics parameters were not included within the equivalence range. Most common adverse events were flu-like symptoms, with no serious adverse event reported. Conclusion: The results assessed by the bioequivalence criterion indicated that the pharmacodynamics of DA-3021 was equivalent to that of PEGASYS®. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 117~126 | - |
dc.relation.isPartOf | Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지) | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | PEG-인터페론 알파-2a 제제 DA-3021의 안전성 및 약동력학적 특성 연구 | - |
dc.title.alternative | The Safety and the Pharmacokinetics and Pharmacodynamics of a Pegylated Interferon Alpha-2a Formulation, Dong-A's DA-3021 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pharmacology (약리학) | - |
dc.contributor.googleauthor | Heon Yung Gee | - |
dc.contributor.googleauthor | Bor Luen Tang | - |
dc.contributor.googleauthor | Kyung Hwan Kim | - |
dc.contributor.googleauthor | Min Goo Lee | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A03436 | - |
dc.contributor.localId | A03709 | - |
dc.contributor.localId | A01422 | - |
dc.contributor.localId | A01999 | - |
dc.contributor.localId | A02740 | - |
dc.contributor.localId | A03023 | - |
dc.contributor.localId | A03383 | - |
dc.relation.journalcode | J01533 | - |
dc.subject.keyword | Interferon alpha-2a | - |
dc.subject.keyword | Pegylation | - |
dc.subject.keyword | Safety | - |
dc.subject.keyword | Pharmacokinetics | - |
dc.subject.keyword | Pharmacodynamics | - |
dc.contributor.alternativeName | Jang, Seong Bok | - |
dc.contributor.alternativeName | Chung, Jae Yong | - |
dc.contributor.alternativeName | Park, Kyung Soo | - |
dc.contributor.alternativeName | Son, Han kil | - |
dc.contributor.alternativeName | Lee, Dong Hwan | - |
dc.contributor.alternativeName | Lee, Yoon Jung | - |
dc.contributor.alternativeName | Lim, Lay Ahyoung | - |
dc.contributor.affiliatedAuthor | Jang, Seong Bok | - |
dc.contributor.affiliatedAuthor | Chung, Jae Yong | - |
dc.contributor.affiliatedAuthor | Park, Kyung Soo | - |
dc.contributor.affiliatedAuthor | Son, Han kil | - |
dc.contributor.affiliatedAuthor | Lee, Dong Hwan | - |
dc.contributor.affiliatedAuthor | Lee, Yoon Jung | - |
dc.contributor.affiliatedAuthor | Lim, Lay Ahyoung | - |
dc.citation.volume | 18 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 117 | - |
dc.citation.endPage | 126 | - |
dc.identifier.bibliographicCitation | Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지), Vol.18(2) : 117-126, 2010 | - |
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