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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artefenomel | Small molecule | 800 mg | Oral |
| Subject | piperaquine | Small molecule | 960 mg | Oral |
| Subject | piperaquine | Small molecule | 1440 mg | Oral |