Population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome
2015 (English)In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 80, no 2, 242-252 p.Article in journal (Refereed) Published
AimThe aim was to investigate the population pharmacokinetics of levamisole in children with steroid-sensitive nephrotic syndrome. MethodsNon-linear mixed effects modelling was performed on samples collected during a randomized controlled trial. Samples were collected from children who were receiving 2.5mg kg(-1) levamisole (or placebo) orally once every other day. One hundred and thirty-six plasma samples were collected from 38 children from India and Europe and included in the analysis. A one compartment model described the data well. ResultsThe apparent clearance rate (CL/F) and distribution volume (V/F) were 44l h(-1) 70kg(-1) and 236l 70kg(-1), respectively; estimated interindividual variability was 32-42%. In addition to allometric scaling of CL/F and V/F to body weight, we identified a significant proportional effect of age on CL/F (-10.1% per year). The pharmacokinetics parameters were not affected by gender, tablet strength or study centre. The median (interquartile range) maximum plasma concentration of levamisole was 438.3 (316.5-621.8) ng ml(-1), and the median area under the concentration-time curve was 2847 (2267-3761) ng ml(-1) h. Median t(max) and t(1/2) values were 1.65 (1.32-2.0) h and 2.60 (2.06-3.65) h, respectively. ConclusionsHere, we present the first pharmacokinetic data regarding levamisole in children with steroid-sensitive nephrotic syndrome. The pharmacokinetic profile of levamisole in children was similar to findings reported in adults, although the elimination rate was slightly higher in children.
Place, publisher, year, edition, pages
2015. Vol. 80, no 2, 242-252 p.
levamisole, nephrotic syndrome, population pharmacokinetics
Pharmaceutical Sciences Pharmacology and Toxicology
IdentifiersURN: urn:nbn:se:uu:diva-260814DOI: 10.1111/bcp.12607ISI: 000358445700010PubMedID: 25677380OAI: oai:DiVA.org:uu-260814DiVA: diva2:849436