Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.
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SUBMITTER: Gonzalez D
PROVIDER: S-EPMC4808196 | biostudies-literature | 2016 Apr
REPOSITORIES: biostudies-literature
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Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.
Gonzalez Daniel D Palazzi Debra L DL Bhattacharya-Mithal Leena L Al-Uzri Amira A James Laura P LP Bradley John J Neu Natalie N Jasion Theresa T Hornik Christoph P CP Smith P Brian PB Benjamin Daniel K DK Keedy Kara K Fernandes Prabhavathi P Cohen-Wolkowiez Michael M
Antimicrobial agents and chemotherapy 20160325 4
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 ...[more]
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