drugset / Trial / NCT01552330

Pharmacokinetic Study of Primaquine and Pyronaridine-Artesunate in Healthy Subjects

NCT01552330

Phase 1 Completed 17 enrolled University of Oxford
RandomizedCrossoverOpen-labelTreatment

Summary

The observed changes of P. falciparum sensitivity to artemisinin lead to the intensification of early detection as well as treatment monitoring in malaria infection. It is widely accepted that the development of resistance can be delayed by the use of combination therapy, especially combinations that include artemisinin derivatives (acts). As the resistance problem is considered extremely serious; as a consequence, who has recommended that all monotherapy for malaria should be stopped. Current WHO guidelines recommend that the drug combination regimens using ACT with effective partner medicines should be used to decrease the risk of development or spreading of artemisinin resistance.

Timeline

Start
2012-05
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Artesunate Small molecule 180 mg Oral
Comparator Dihydroartemisinin-piperaquine Unknown
Subject Primaquine Small molecule 30 mg Oral
Subject Pyronaridine Unknown 540 mg Oral

Indications

No indication recorded.