Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot

(Details available on request)

Inclusion criteria

• Absence of current drug treatment (except hormonal contraception, an additional barrier method is strongly advised)
• 12-lead ECG without significant abnormalities
• The subject understands the procedures, agrees to participate and is willing to give written informed consent
• The subject agrees to be available for at least 5 blood sampling after drug administration, at scheduled time points.

Exclusion criteria

• History of any major medical disorder
• Any recent acute illness which could expose the subject to a higher risk or might confound the results of the study
• Current pregnancy or breast-feeding
• Congenital prolongation of the QT interval (e.g., long QT syndrome) or any other clinical condition known to prolong the corrected QT interval
• Family history of congenital prolongation of the QT interval or sudden death
• Known disturbances of electrolyte balance
• Known liver disorder of any type, even if no medical treatment is needed. Gilbert syndrome will be tolerated, if mild
• Treatment in the previous three months with any drug known to have well-defined potential for toxicity to a major organ
• History of hypersensitivity to any component of the drug
• History of hypersensitivity to any drug if considered as serious
• History of alcohol or drug abuse
• Present consumption of a large quantity of alcohol or wine (>0.5 L wine/day) or equivalent. Consumption of reasonable amount of wine (0.3 L) or of beer is acceptable, except between Day -1 to Day 3 of drug administration
• Use of any medication the week prior to study or as based on 5 plasma half-life rule and up to 48 hours post drug administration
• Participation in a clinical trial in the previous 3 months unless no treatment provided and low amount of blood collected
• Occupation which might interfere with visits and blood sampling during the study
• Psychological status which could have an impact on subject's ability to give informed consent
• Any feature of subject's medical history or present condition which, in the investigator's opinion, could confound the results of the study, complicate their interpretation or represent a potential risk for the subject