drugset / Trial / NCT01868438

Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations in Healthy Volunteers

NCT01868438

RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study is to compare the bioavailability of two formulations (tablets and granules for dispersion) of the antimalarial drug pyronaridine-artesunate \[3:1\] (Pyramax, PA) in healthy adults. The secondary objective is to compare the safety of the two PA formulations and liver function test changes following the first and second administrations.

Timeline

Start
2013-05
Primary completion
2013-10
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Artesunate Small molecule 180 mg
Comparator Pyronaridine Unknown 540 mg

Indications