Malaria Infections and Infestations Malaria
Conditions
Interventions
Artesunate tablet 50 mg. Amodiaquine tablet (153 mg base/tablet).
Combination of artesunate/amodiaquine (100 mg and 270 mg, respectively).
For both arms, a single dose of appropriate drug(s) will be t
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male/female age 21 - 45 years 2. Written consent 3. Voluntary participation fully aware of possible side effects 4. No significant abnormal findings on history or examination, particularly no prior liver disease, cardiovascular disease or peripheral neuropathy 5. No clinically significant abnormalities on haematology, liver and renal function tests 6. Non pregnant on test (women) 7. Normal electrocardiogram (ECG) 8. No history of antimalarial ingestion (chloroquine, amodiaquine, quinine, halofantrine, pyrimethamine-sulfadoxine associated or not to mefloquine) in the preceding two months 9. No other drugs or medications, including over-the-counter preparations, ingested in the preceding week 10. Adequate venous access
Exclusion criteria
Exclusion criteria: 1. Refusal of consent 2. Biological or electrocardiographic anomalies 3. Presence of hepatic, renal and gastrointestinal disorders 4. Smokers (>10/day), abuse of alcohol or recreational drugs 5. Presence of malaria parasites on a thick smear 6. Subjects having been in a malarial area in the preceding 8 weeks 7. Subjects having ingested drugs in the preceding week 8. Presence of acute or chronic infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Malaysia
Outcome results
None listed