Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.
Antimicrob Agents Chemother
; 60(4): 2572-6, 2016 Apr.
Article
em En
| MEDLINE
| ID: mdl-26883693
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.).
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Infecções Bacterianas
/
Triazóis
/
Macrolídeos
/
Antibacterianos
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Child
/
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article