drugset / Trial / NCT01958619

Open Label Pharmacokinetic Study of OZ439 and Piperaquine on Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in Healthy Volunteers

NCT01958619

RandomizedParallel-groupOpen-labelTreatment

Summary

A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Artefenomel Small molecule 800 mg Oral
Subject piperaquine Small molecule 960 mg Oral
Subject piperaquine Small molecule 1440 mg Oral

Indications