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Pharmacokinetic and Pharmacodynamic Study of Mefloquine and Dihydroartemisinin-Piperaquine in Healthy Subjects

NCT02324738 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-11-03

No results posted yet for this study

Summary

This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol university.

The 16 subjects have already participated in a healthy volunteer studies in the past either i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered primaquine and dihydroartemisinin-piperaquine (DHA-PQP) in Healthy Adult Subjects or ii) Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine and piperaquine in healthy Thai subjects

Every subject was administered a single dose of three tablets of DHA-PQP from previous studies. To avoid unnecessary exposure of DHA-PQP again, we propose to include the results of DHA-PQP arm from these previous studies and ask the healthy subjects to participate this study for receiving only single dose of three tablet of DHA-PQP (40mg/320mg) and two tablet of Mefloquine (250mg) on first admission and single dose of two tablet of Mefloquine on second admission.

Conditions

  • Healthy

Interventions

DRUG

Mefloquine and Dihydroartemisinin-piperaquine

2 tablets of mefloquine and 3 tablets of dihydroartemisinin-piperaquine single dose

OTHER

Wash-out period

DRUG

Mefloquine

2 tablets of Mefloquine single dose

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

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 NCT02324738 on ClinicalTrials.gov