Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 7, 2014

Primary Completion Date

July 27, 2014

Study Completion Date

June 1, 2015

Conditions
Plasmodium FalciparumMalaria, Falciparum
Interventions
DRUG

artemisinin/naphthoquine

"Each tablet of ARCO (artemisinin/naphthoquine) contains 125 mg artemisinin and 50 mg of naphthoquine. The total dose for adults will be 1000mg of artemisinin and 400mg of naphthoquine in a fixed oral dose (ARCO tablet).~The regimen for children will be calculated according to the body weight (20mg artemisinin + 8mg naphthoquine per kg body weight in a fixed oral dose(ARCO tablet))."

DRUG

dihydroartemisinin/piperaquine phosphate

Eurartesim (dihydroartemisinin/piperaquine phosphate) is a fixed dose preparation with two dose-strengths (20 mg dihydroartemisinin and 160mg of piperaquine phosphate and 40mg dihydroartemisinin and 320mg of piperaquine phosphate. The regimen for patients with body weight of 36-75kg is three tablets of 40mg dihydroartemisinin and 320mg of piperaquine phosphate once daily for three consecutive days. Those beyond or below this range the regimen will be calculated based on the body weight.

Trial Locations (1)

74

Ifakara Health Institute, Bagamoyo

All Listed Sponsors
lead

Ifakara Health Institute

OTHER

NCT01930331 - Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO | Biotech Hunter | Biotech Hunter