Inclusion Criteria:

Male or female with a body weight ≥10 to 40 kg

• Patients suffering from acute uncomplicated Plasmodium falciparum malaria
• Malaria diagnosis confirmed by a positive blood smear with asexual forms of Plasmodium falciparum (i.e., identification of asexual parasite count ≥1,000 to 250,000 per mm3)
• Ear temperature  37.5°C or a history of fever within the last 48 hours
• Haemoglobin  7g/100ml
• Written informed consent and written consent from parents/guardian for children below age of consent (verbal consent in presence of literate witness is required for illiterate patients or parents/guardians).

Exclusion Criteria:

Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment (defined according to WHO Recommendations “Malaria Control Today”, RBM Working Document, March 2005, see Appendix 2)

• Patients with known hypersensitivity or allergy to artemisinin derivatives or mefloquine or mefloquine chemically related compounds (for example quinine and quinidine)
• Patients who had received quinine or any artemisinin derivatives within 12 hours prior to study start
• Patients who had received any other adequate antimalarial drug therapy including antibiotics which might be active against malaria infection within 1 week prior to study start
• Patients who had received investigational (unlicensed) drugs as well as mefloquine within 30 days prior to study start
• Patients with known history of psychiatric disorders
• Patients with known history of cardiac diseases and arrhythmia
• Patients with known sickle cell disease
• Patients with clinical signs of or laboratory evidence for any other severe hepatic, renal, pulmonary, cardiac, metabolic, psychiatric, cancer or haematologic diseases
• Pregnancy or lactation