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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Oct 2017

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At a glance

  • Drugs Dihydroartemisinin/piperaquine (Primary)
  • Indications Falciparum malaria
  • Focus Pharmacokinetics
  • Sponsors sigma-tau SpA
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 23 Oct 2017 Primary endpoint (PCR-corrected Adequate Clinical and Parasitological Response (ACPR), dispersible tablet formulation of DHA/PQP Vs crushed tablet) has been met as per the results published in the Antimicrobial Agents and Chemotherapy
    • 23 Oct 2017 Results published in the Antimicrobial Agents and Chemotherapy
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