drugset / Trial / NCT01383096

Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

NCT01383096

RandomizedCrossoverOpen-labelTreatment

Summary

This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.

Timeline

Start
2012-04
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Artefenomel Small molecule 400 mg Oral
Subject Artefenomel Small molecule 800 mg Oral

Indications

No indication recorded.