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PEG-인터페론 알파-2a 제제 DA-3021의 안전성 및 약동력학적 특성 연구

Other Titles
 The Safety and the Pharmacokinetics and Pharmacodynamics of a Pegylated Interferon Alpha-2a Formulation, Dong-A's DA-3021 
 Heon Yung Gee  ;  Bor Luen Tang  ;  Kyung Hwan Kim  ;  Min Goo Lee 
 Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지), Vol.18(2) : 117-126, 2010 
Journal Title
 Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지) 
Issue Date
Interferon alpha-2a ; Pegylation ; Safety ; Pharmacokinetics ; Pharmacodynamics
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®.
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1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers
Yonsei Authors
Park, Kyungsoo(박경수) ORCID logo https://orcid.org/0000-0002-6972-1143
Son, Han kil(손한길)
Lee, Dong Hwan(이동환)
Lee, Yoon Jung(이윤정)
Lim, Lay Ahyoung(임아영)
Jang, Seong Bok(장성복)
Chung, Jae Yong(정재용)
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