At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
14C-labeled Pyronaridinedrug
Likely dose
14C-labeled Pyronaridine 720 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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A Human Mass Balance Study of Pyronaridine Using Accelerator Mass Spectrometry
In Brief
A Phase 1 clinical trial evaluating 14C-labeled Pyronaridine for Malaria. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The combination of pyronaridine and artesunate is an antimalarial therapy in development. This mass balance study is intended to determine the rate and extent of excretion of total radioactivity in urine and feces following administration of a single oral micro-dose of 14C-pyronaridine in humans.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesSwitzerland
CollaboratorsShin Poong Pharmaceuticals
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionSep 2011
Study CompletionDec 2011
TodayJul 2026
First PostedJun 28, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.0 years ago
Interventions
14C-labeled Pyronaridinedrug
Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).