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NOT YET RECRUITING
NCT07470424
PHASE1

A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults

Sponsor: University of Oxford

View on ClinicalTrials.gov

Summary

This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups. Each group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders. After each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen. This study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.

Official title: A Randomized, Open-Label Crossover Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Piperaquine, Pyronaridine and Artesunate in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06-01

Completion Date

2027-08-01

Last Updated

2026-04-06

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Piperaquine

Piperaquine is an antimalarial medicine normally combined with an artemisinin derivative in the combination therapy dihydroartemisinin-piperaquine.

DRUG

Artesunate-pyronaridine (Pyramax)

Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.

DRUG

Piperaquine and artesunate-pyronaridine (Pyramax)

Piperaquine is an antimalarial medicine. Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.

Locations (1)

Medical Therapeutic Unit, Faculty of Tropical Medicine

Bangkok, Thailand