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KMID : 0391020100180020117
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2010 Volume.18 No. 2 p.117 ~ p.126
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The Safety and the Pharmacokinetics and Pharmacodynamics of a Pegylated Interferon Alpha-2a Formulation, Dong-A’s DA-3021
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Son Han-Kil
Lim Lay-Ahyoung
Lee Dong-Hwan
Jang Seong-Bok
Lee Yoon-Jung
Chung Jae-Yong
Park Kyung-Soo
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Abstract
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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 of 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 and . The pharmacodynamics were assessed by 2’,5’-OAS (oligoadenylate synthetase) using a radioimmunoassay (RIA). The primary pharmacodynamic parameters were and .
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 and 0.92-1.05 for , 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 .
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KEYWORD
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Interferon alpha-2a, Pegylation, Safety, Pharmacokinetics, Pharmacodynamics
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