Journal article
Population pharmacokinetics of artesunate and amodiaquine in African children
K Stepniewska, W Taylor, SB Sirima, EB Ouedraogo, A Ouedraogo, A Gansané, JA Simpson, CC Morgan, NJ White, JR Kiechel
Malaria Journal | BMC | Published : 2009
Abstract
Background. Pharmacokinetic (PK) data on amodiaquine (AQ) and artesunate (AS) are limited in children, an important risk group for malaria. The aim of this study was to evaluate the PK properties of a newly developed and registered fixed dose combination (FDC) of artesunate and amodiaquine. Methods. A prospective population pharmacokinetic study of AS and AQ was conducted in children aged six months to five years. Participants were randomized to receive the new artesunate and amodiaquine FDC or the same drugs given in separate tablets. Children were divided into two groups of 70 (35 in each treatment arm) to evaluate the pharmacokinetic properties of AS and AQ, respectively. Population pharm..
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Funding Acknowledgements
The contribution of the whole team of the CNRFP in Ouagadougou (Burkina Faso) is gratefully acknowledged. We thank the team for the dedication to the study and the careful management of the patients. We thank the Synexel Laboratories for performing the bioanalytical determinations and Sanofi-Aventis for providing stable isotope labelled internal standards for bioanalytical work as well as for the study drugs, and Cardinal Systems for data management and the CSR preparation. Dr. Jayme Fernandes was the study monitor and his valuable contribution is highly appreciated. We are grateful to the DNDi FACT management team for their support and the useful discussions with Dr. P. Olliaro and Professor V. Navaratnam.