At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Pyronaridine-artesunate granules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1, Open-label, Cross-over Study to Investigate the Relative Bioavailability of Pyramax (Pyronaridine-artesunate) in Tablet and Granule Formulations, in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Pyronaridine-artesunate granules and Pyronaridine-artesunate tablets for Malaria. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesSouth Korea
CollaboratorsShin Poong Pharmaceutical Co. Ltd.
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedJun 2013
Primary CompletionOct 2013
Study CompletionJan 2014
TodayJul 2026
First PostedJun 4, 2013
Enrollment StartMay 1, 2013
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.1 years ago
Interventions
Pyronaridine-artesunate granulesdrug
Pyronaridine-artesunate tabletsdrug