Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.
Status:
Completed
Trial end date:
2024-01-03
Target enrollment:
Participant gender:
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.