Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.

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.

Timeline

Start

2023-08-14

Primary completion

2023-12-06

Completion

2024-01-03

Drugs

Indications