CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
pyronaridine artesunate clinical trial reference tablets +1 moredrug
Likely dose
pyronaridine artesunate clinical trial reference tablets 240 mgfrom 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.

Search/NCT00682630
NCT00682630Phase 1Completed
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Phase I, Randomized, Single Dose, Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet

Medicines for Malaria Venture·interventional·Posted May 22, 2008·Updated Feb 3, 2023

In Brief

A Phase 1 clinical trial evaluating pyronaridine artesunate clinical trial reference tablets and pyronaridine artesunate to-be-marketed tablets for Malaria. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The primary objective of this study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. The secondary objective is to assess the safety of the two formulations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesSwitzerland
CollaboratorsShin Poong Pharmaceuticals

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2008
Enrollment StartSep 1, 2007
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.1 years ago

Interventions

pyronaridine artesunate clinical trial reference tabletsdrug

Single total oral dose of 720:240 mg (4 tablets of 180:60 mg)

pyronaridine artesunate to-be-marketed tabletsdrug

Single total oral dose of 720:240 mg (4 tablets of 180:60 mg)