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NCT05930782

Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.[PedPQP (BA/FE)]

A Randomized, Open Label, Two-part, Parallel-group, Phase I Study to Evaluate the Pharmacokinetics of Piperaquine Oral Dispersible Granules Formulation Compared to Piperaquine Hard Tablets Administered as a Single Dose in Fasting Condition (Part 1) and of Piperaquine Oral Dispersible Granules Formulation Administered as Single Dose in Various Fed States (Part 2) in Healthy Adult Participants
Medicines for Malaria Venture·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Malaria
Drug/Device/Intervention
Piperaquine Phosphate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Medicines for Malaria Venture
Timeline & enrollment
Phase
Phase 1
Start date
Jul 01, 2023
End date
Dec 01, 2023
Enrollment
60 participants
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
Unspecified malariaPlasmodium malariae malariaPlasmodium falciparum malariaOther parasitologically confirmed malariaPlasmodium ovale malaria
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05930782
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05930782 through Pure Global AI's free database. This Phase 1 trial is sponsored by Medicines for Malaria Venture and is currently Not yet recruiting. The study focuses on Malaria. Target enrollment is 60 participants.

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