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

NCT05930782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-18

Study results available
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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.

Conditions

Interventions

DRUG

Piperaquine Tetraphosphate uncoated tablets

Piperaquine tetraphosphate hard tablet 320 mg; single dose (320 mg) given orally with 240 ml of water

DRUG

Piperaquine Tetraphosphate dispersible granules

Piperaquine tetraphosphate dispersible granules 320 mg dose equivalent dispersed in 25 ml of water; single dose (320 mg) given orally

Sponsors & Collaborators

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Florence A Milando, MD, MPH · Ifakara Health Institute (IHI), Tanzania

  • Said A Jongo, MD, MMed, PhD · Ifakara Health Institute (IHI), Tanzania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2023-12-06
Completion
2024-01-03

Countries

  • Tanzania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05930782 on ClinicalTrials.gov