Pharmacokinetic

Healthy

Drug Combination

Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks

Artemether-lumefantrine

Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

Amodiaquine

Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2

Artemether-lumefantrine + Amodiaquine

Faculty of Tropical Medicine, Mahidol University

Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects

A Randomized, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions of Orally Administered Artemether-lumefantrine and Amodiaquine in Healthy Adult Subjects

of artemether, lumefantrine and amodiaquine and their metabolites when given alone and in combination.

Adverse events will be assessed as one of safety and tolerability parameters.

Electrocardiographic changes especially QTc interval prolongation will be assessed as one of safety and tolerability parameters.

Abnormal vital signs will be assessed as one of safety and tolerability parameters.

Abnormal laboratory values will be assessed as one of safety and tolerability parameters.

Genotyping will be performed to identify polymorphisms of cytochrome 450 and other enzymes related to drug metabolism from subject who is an unusual metabolizer.

With subject's consent, subject's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future.

University of Oxford

Mahidol University

Mahidol Oxford Tropical Medicine Research Unit

This is an open-label pharmacokinetic study in 16 healthy Thai subjects. Subjects will be admitted in the inpatient ward and will be randomized to group A or group B to receive 3 drug regimens (Regimen 1 Artemether-lumefantrine; Regimen 2 Amodiaquine ; Regimen 3 Artemether-lumefantrine + Amodiaquine) on Day 0, 1, and 2. Every subject will have 1 screening and 3 admissions in the hospital.

artemether/hepatitis

Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects

Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults

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