Pharmacokinetic and Pharmacodynamic Study of Mefloquine and Dihydroartemisinin-Piperaquine in Healthy Subjects
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
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.