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Pharmacokinetic Study of Primaquine and Pyronaridine-Artesunate in Healthy Subjects

NCT01552330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-08-28

No results posted yet for this study

Summary

The observed changes of P. falciparum sensitivity to artemisinin lead to the intensification of early detection as well as treatment monitoring in malaria infection. It is widely accepted that the development of resistance can be delayed by the use of combination therapy, especially combinations that include artemisinin derivatives (acts). As the resistance problem is considered extremely serious; as a consequence, who has recommended that all monotherapy for malaria should be stopped.

Current WHO guidelines recommend that the drug combination regimens using ACT with effective partner medicines should be used to decrease the risk of development or spreading of artemisinin resistance.

Conditions

  • Healthy

Interventions

DRUG

Primaquine and Pyronaridine-artesunate

Subject will receive primaquine (PQ) then receive pyronaridine-artesunate (PA)after 1 week washout period and receive PQ together with PA for the third regimen after 8 weeks washout period Primaquine: \- Dosage: 2 tablets and Pyronaridine-Artesunate: \- Dosage: 3 tablets

DRUG

Primaquine and Pyronaridine-Artesunate

Subject will receive primaquine (PQ) then receive PQ together dihydroartemisinin-piperaquine (DHA-PQP) after 1 week washout period and receive DHA-PQP for the third regimen after 8 weeks washout period. Primaquine: \- Dosage: 2 tablets and Pyronaridine-Artesunate: \- Dosage: 3 tablets

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Podjanee Jittamala, MD · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Thailand

Study Locations

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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 NCT01552330 on ClinicalTrials.gov