Comparative pharmacokinetics and pharmacodynamics of two recombinant human interferon beta-1a (IFN beta-1a) products administered intramuscularly in healthy male and female volunteers
Comparative pharmacokinetics and pharmacodynamics of two recombinant human interferon beta-1a (IFN beta-1a) products administered intramuscularly in healthy male and female volunteers
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DOI：
10.1023/a:1012128406432
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发表时间：
1997-04-01
影响因子：
3.7
通讯作者：
Rogge, M
中科院分区：
文献类型：
--
作者：
Alam, J;Goelz, S;Rogge, M
方法研究设计这是一项随机、开放、单中心、双处理、交叉试验，旨在比较Avonex(TM)和Rebif®在健康志愿者肌注后的药代动力学和药效学特征。男性和女性受试者，年龄在18岁到45岁之间，身高在正常体重的15%以内，最低体重为50公斤，并给予书面知情同意，符合这项研究的条件。
METHODSStudy DesignThis was a randomized, open-label, single-center, twotreatment, crossover study designed to compare the pharmacokinetic and pharmacodynamic profiles of AVONEX (TM) and Rebif® after IM injection in healthy volunteers. Male and female subjects, aged between 18 and 45 years, who were within 15% of normal body weight for height with a minimum body weight of 50 kg, and who gave written informed consent, were eligible for this study.