drugset / Trial / NCT01594931
Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
Phase 2
Completed
477 enrolled
Medicines for Malaria Venture
Shin Poong Pharmaceutical Co. Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.
Timeline
- Start
- 2005-07
- Primary completion
- 2006-03
- Completion
- 2006-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 2 mg/kg | Oral |
| Subject | Artesunate | Small molecule | 3 mg/kg | Oral |
| Subject | Artesunate | Small molecule | 4 mg/kg | Oral |
| Subject | Pyronaridine | Unknown | 6 mg/kg | Oral |
| Subject | Pyronaridine | Unknown | 9 mg/kg | Oral |
| Subject | Pyronaridine | Unknown | 12 mg/kg | Oral |