Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.[PedPQP (BA/FE)] - Trial NCT05930782
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Study Focus
Sponsor & Location
Medicines for Malaria Venture
Timeline & Enrollment
Phase 1
Jul 01, 2023
Dec 01, 2023
Primary Outcome
Relative bioavailability (Frel) of the Maximum Observed Plasma Concentration (Cmax) of the PQP dispersible granule compared to the PQP hard tablet in the fasted state (Frel Cmax).,Relative bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 72h hours (AUC0-72h) of the PQP dispersible granule compared to the PQP hard tablet in the fasted state (Frel AUC0-72h).,Relative bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to the last quantifiable concentration (AUC0-t) of the PQP dispersible granule compared to the PQP hard tablet in the fasted state (Frel AUC0-t).,Relative bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero to 168 hours (AUC0-168h) of the PQP dispersible granule compared to the PQP hard tablet in the fasted state (Frel AUC0-168h.,Relative bioavailability (Frel) of the Area Under the Plasma Concentration-time Curve From Time Zero extrapolated to infinity (AUC0-∞) of the PQP dispersible granule compared to the PQP hard tablet in the fasted state (Frel AUC0-∞).
Summary
This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure
 of a single oral dose of piperaquine (PQP) in a dispersible granule formulation compared to
 the PQP hard tablet formulation in the fasted state (Part 1), to advise the selection of dose
 when the PQP granule formulation is administered in a fed state in healthy adult
 participants. Part 2 will assess the effect on different types of meal composition on the PK
 of a single dose of PQP granule formulation in healthy adult participants.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05930782
Non-Device Trial