CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Pyronaridine-Artesunatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00331136
NCT00331136Phase 2Completed
CompareCT.gov

An Open-label, Phase II, Dose-Escalation Clinical Study to Assess the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Fixed Dose Combination of Pyronaridine and Artesunate (3:1) in Children With Acute Falciparum Malaria

Medicines for Malaria Venture·interventional·Posted May 29, 2006·Updated May 5, 2022

In Brief

A Phase 2 clinical trial evaluating Pyronaridine-Artesunate for Uncomplicated Plasmodium Falciparum Malaria. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUncomplicated Plasmodium Falciparum Malaria
CountriesGabon
CollaboratorsShin Poong Pharmaceuticals, Institute of Tropical Medicine, University of Tuebingen

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 29, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.1 years ago

Interventions

Pyronaridine-Artesunatedrug

Once a day for 3 days