Population pharmacokinetics of artesunate and amodiaquine in African children

by Stepniewska K, Taylor W, Sirima SB, Ouedraogo EB, Ouedraogo A, Gansane A, Simpson JA, Morgan CC, White NJ, Kiechel JRMalaria Journal, August 2009, 8:200.

Summary. Pharmacokinetic (PK) data on amodiaquine (AQ) and artesunate (AS) are limited in children, an important risk group for malaria. The aim of this prospective population pharmacokinetic study of AS and AQ was to evaluate the PK properties of “ASAQ”, a newly developed and registered fixed dose combination (FDC) of AS and AQ in African children. Conducted in 70 children aged six months to five years, the study utilized population PK models for dihydroartemisinin (DHA) and desethylamodiaquine (DeAq), the principal pharmacologically active metabolites of AS and AQ, respectively, and total artemisinin anti-malarial activity. Relative bioavailability between products was compared by estimating the ratios (and 95% CI) between the areas under the plasma concentration-time curves (AUC). The bioavailability of the co-formulated AS-AQ FDC was similar to that of the separate tablets for desethylamodiaquine, DHA and the total anti-malarial activity. These data support the use this new AS-AQ FDC in children with acute uncomplicated falciparum malaria.

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