A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
There is a need for paediatric formulations that permit accurate dosing and enhance patient
compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations
are available on the market. Thus, a new water dispersible formulation of eurartesim has been
developed for oral administration.
Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this
new paediatric formulation and compare it with the crushed film coated tablet in infant
patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum malaria.
Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to establish
PK/PD relationship in adult and paediatric populations.