A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria

PHASE2CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

July 31, 2015

Study Completion Date

January 31, 2016

Conditions
Malaria,Falciparum
Interventions
DRUG

Eurartesim dispersible oral tablet

The first dose of Eurartesim dispersible oral tablet will be administered immediately after randomization. the other two doses will be administered with an interval of 24 hours. Eurartesim tablet will be dispersed in about 10 mL of water.

DRUG

eurartesim film coated tablet

The first dose of Eurartesim film coated tablet will be administered immediately after randomization. the other two doses will be administered with an interval of 24 hours. tablet will be crushed and dispersed in a few amount of water (about 10 ml).

Trial Locations (7)

Unknown

Centre Muraz, Bobo-Dioulasso

Centre National de Recherche et de Formation en Paludisme, Ouagadougou

Kinshasa School of Public Health, School of Medicine, University of Kinshasa, Kinshasa

Manica's Health Research Centre, Manica

Bagamoyo Research center, Ifakara Heath Institute, Bagamoyo

National Insititute for Medical Research, Tanga

Medical Research Council, Fajara

All Listed Sponsors
lead

sigma-tau i.f.r. S.p.A.

INDUSTRY

NCT01992900 - A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria | Biotech Hunter | Biotech Hunter