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KMID : 0391020110190020144
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2011 Volume.19 No. 2 p.144 ~ p.151
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Pharmacokinetics and Tolerability Evaluation of Human Coagulation Recombinant Factor VIII () in Hemophilia A Patients
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Han Hye-Kyung
Shin Kwang-Hee
Paik Sang-Hoon
Chung Jae-Yong
Lim Kyoung-Soo
Cho Joo-Youn
Yoon Seo-Hyun
Jang In-Jin
Yu Kyung-Sang
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Abstract
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Background: (Green Cross Corp.) is a recombinant clotting factor VIII which is used for hemophilia A. This study aimed to investigate the pharmacokinetics and safety profiles of 25 IU/kg and 50 IU/kg of in Korean hemophilia A patients.
Methods: A dose-block randomized, single-blind, active drug-controlled, single and multiple dose, parallel-group study was conducted with 16 hemophilia A patients (25 IU/kg: 50 IU/kg = 8:8). They received or (active control) intravenously on day 1 and every other day from day 4 to 10. FVIII:C (Factor VIII procoagulant activity) was measured to determine the pharmacokinetics (PK) at baseline and up to 48 hours for single and multiple administration. PK parameters were determined using noncompartmental methods.
Results: The maximum concentration () and the area under the concentration-time curve () of the 25 IU/kg () were % and respectively, while those of 50 IU/kg were % and after single administration. The and in steady state of the 25 IU/kg were % and , while those of 50 IU/kg were % and . No serious adverse event was observed.
Conclusion: The to hemophilia A patients appeared to be well tolerated within range of 25-50 IU/kg. The PK parameters of factor VIII showed dose-independent manner with 25 IU/kg and 50 IU/kg dose ranges.
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KEYWORD
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Hemophilia A, Recombinant factor VIII, Pharmacokinetics, Korean
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