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A Phase II, Open-label, Multicentre, Pharmacokinetic, Pharmacodynamics and Safety Study of a New Paediatric Eurartesim Dispersible Formulation and Crushed Film Coated Eurartesim Tablet, in Infant Patients With P. Falciparum Malaria
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.
Details
| Lead sponsor | sigma-tau i.f.r. S.p.A. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 300 |
| Start date | 2013-11 |
| Completion | 2016-01 |
Conditions
- Malaria,Falciparum
Interventions
- Eurartesim dispersible oral tablet
- eurartesim film coated tablet
Primary outcomes
- Comparison of peak plasma concentration of Dihydroartemisinin in the two studied formulations — DHA plasma samples will be collected on the first day of study drug administration at 20, 30, 40, 60, 100, 200 and 300 minutes post-dose
In order to minimize the blood sampling in infants, patients will be divided into 10 blood sampling groups for both the treatments (water dispersible and crushed film coated tablet) and only 2 blood draws per group will be taken within the prespecified timepoints. Optimal sampling design was performed by using the appropriate software. The D-optimal design option was used to determine the optimal sampling design. - Comparison of area under the plasma concentration versus time curve of Dihydroartemisinin in the two studied formulations. — DHA plasma samples will be collected on the first day of study drug administration at 20, 30, 40, 60, 100, 200 and 300 minutes post-dose
In order to minimize the blood sampling in infants, patients will be divided into 10 blood sampling groups for both the treatments (water dispersible and crushed film coated tablet) and only 2 blood draws per group will be taken within the pre-specified timepoints. Optimal sampling design was performed by using the appropriate software. The D-optimal design option was used to determine the optimal sampling design. - Comparison of peak plasma concentration of Piperaquine in the two studied formulations — PQP plasma samples will be collected on day 0 of treatment at 40, 80, 280, 720 minutes, then on day 1 at 24 hours and on day 2 at 40, 80, 280, 720 minutes after the last drug administration and then 24, 120, 288 and 456 hours
In order to minimize the blood sampling in infants, patients will be divided into 10 blood sampling groups for both the treatments (water dispersible and crushed film coated tablet) and only 2 blood draws per group will be taken within the pre-specified timepoints. Optimal sampling design was performed by using the appropriate software. The D-optimal design option was used to determine the optimal sampling design. - Comparison of area under the plasma concentration versus time curve of Piperaquine in the two studied formulations. — PQP plasma samples will be collected on day 0 of treatment at 40, 80, 280, 720 minutes, then on day 1 at 24 hours and on day 2 at 40, 80, 280, 720 minutes after the last drug administration and then 24, 120, 288 and 456 hours
In order to minimize the blood sampling in infants, patients will be divided into 10 blood sampling groups for both the treatments (water dispersible and crushed film coated tablet) and only 2 blood draws per group will be taken within the pre-specified timepoints. Optimal sampling design was performed by using the appropriate software. The D-optimal design option was used to determine the optimal sampling design.
Countries
Burkina Faso, Democratic Republic of the Congo, Mozambique, Tanzania, The Gambia