Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents
Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents
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DOI：
10.1128/aac.02561-15
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发表时间：
2016-04-01
影响因子：
4.9
通讯作者：
Cohen-Wolkowiez, Michael
中科院分区：
文献类型：
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作者：
Gonzalez, Daniel;Palazzi, Debra L.;Cohen-Wolkowiez, Michael
我们在一项1期、开放标签、多中心的研究中评估了solithromycin（一种氟酮类抗生素）的药代动力学和安全性，该研究纳入了13名疑似或确诊细菌感染的青少年。第3 ~ 5天，0 ~ 24 h平均（标准差）最大血药浓度为0.74 μ g/ml (0.61 μ g/ml)，浓度-时间曲线下面积为9.28 μ g/ml （6.30 μ g/ml）。这一小群青少年的暴露和安全性与成年人相当。
We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 mu g/ml (0.61 mu g/ml) and 9.28 mu g.h/ml (6.30 mu g.h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults.