索利霉素在青少年血浆和干血斑中的药代动力学及安全性
Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.
作者信息
Gonzalez Daniel, Palazzi Debra L, Bhattacharya-Mithal Leena, Al-Uzri Amira, James Laura P, Bradley John, Neu Natalie, Jasion Theresa, Hornik Christoph P, Smith P Brian, Benjamin Daniel K, Keedy Kara, Fernandes Prabhavathi, Cohen-Wolkowiez Michael
机构信息
Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
Infectious Diseases Section, Baylor College of Medicine, Houston, Texas, USA.
出版信息
Antimicrob Agents Chemother. 2016 Mar 25;60(4):2572-6. doi: 10.1128/AAC.02561-15. Print 2016 Apr.
Abstract
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 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.).
摘要
我们在一项针对13名疑似或确诊细菌感染青少年的1期开放标签多中心研究中，评估了氟代酮内酯类抗生素索利霉素的药代动力学和安全性。在第3至5天，平均（标准差）最大血浆浓度和0至24小时浓度-时间曲线下面积分别为0.74μg/ml（0.61μg/ml）和9.28μg·h/ml（6.30μg·h/ml）。这一小群青少年的暴露情况和安全性与成年人相当。（本研究已在ClinicalTrials.gov注册，注册号为NCT01966055。）
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