drugset / Trial / NCT01868438
Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations in Healthy Volunteers
Phase 1
Completed
60 enrolled
Medicines for Malaria Venture
Shin Poong Pharmaceutical Co. Ltd. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artesunate | Small molecule | 180 mg | — |
| Comparator | Pyronaridine | Unknown | 540 mg | — |