At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo Controlled, Parallel Group Study in Healthy Adult Volunteers to Determine the Tolerability and Safety of Pyronaridine (PYR) Co-administered With Piperaquine (PQP) Under Fasted Conditions
In Brief
A Phase 1 clinical trial evaluating Pyronaridine Tetraphosphate, Piperaquine tetraphosphate, and 1 other intervention for Healthy. Completed, enrolled 37 participants across 1 site.
Detailed Summary
The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
Study Details
Timeline
Interventions
A total of 24 participants will be dosed with pyronaridine tetraphosphate, sixteen participants will be additionally be dosed with piperaquine tetraphosphate, eight patients will additionally be dosed with placebo.
A total of 24 participants will be dosed with piperaquine tetraphosphate, sixteen participants will be additionally be dosed with pyronaridine tetraphosphate, eight patients will additionally be dosed with placebo.
Placebo tablets will be administered in combination with pyronaridine tetraphosphate (8 patients), OR, in combination with piperaquine tetraphosphate (8 patients), OR, only matched placebo tablets will be administered (8 patients)