NCT07470424

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will enroll 24 healthy Thai participants. Participants will complete one screening visit and three inpatient study periods. Participants will be randomly assigned to one of six study groups and will receive three different study drugs in a crossover design, as described below: * Study drug 1: Piperaquine * Study drug 2: Pyronaridine and artesunate * Study drug 3: Piperaquine, pyronaridine and artesunate Each treatment study drug will be administered for three consecutive days. The order of administration will differ by study group as follows: Group 1 (n = 4): Study drug 1 → Study drug 2 → Study drug 3 Group 2 (n = 4): Study drug 1 → Study drug 3 → Study drug 2 Group 3 (n = 4): Study drug 2 → Study drug 1 → Study drug 3 Group 4 (n = 4): Study drug 2 → Study drug 3 → Study drug 1 Group 5 (n = 4): Study drug 3 → Study drug 1 → Study drug 2 Group 6 (n = 4): Study drug 3 → Study drug 2 → Study drug 1 After each treatment period, participants will be followed for six weeks, during which seven follow-up visits will be conducted for clinical assessments and blood sampling. A washout period of at least eight weeks will be observed between treatment periods to allow for complete elimination of the study drugs from the body. Each participant will take part in the study for about 6 months. The entire study is expected to last about 12 months.

Conditions

• Malaria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2026-03-13
• Last updated: 2026-04-06

Locations

1 site across 1 country: Thailand