drugset / Trial / NCT04002687
Determine the Tolerability and Safety of Atovaquone-proguanil (ATV-PG) Co-administered With Amodiaquine (AQ)
RandomizedFactorialQuadruple-blindPrevention
Summary
The aim of the study is to determine the tolerability and safety of ATV-PG + AQ, ATV-PG + AQ placebo, ATV-PG placebo + AQ, and ATV-PG placebo + AQ placebo administered once daily for 3 days to healthy adult male and female subjects.This study in healthy adults is the first step towards establishing the tolerability and safety of the approved doses of ATV-PG and AQ when co-administered. If considered acceptable based on the findings of this study, the tolerability, safety and PE will subsequently be assessed, within the target geographical areas.
Timeline
- Start
- 2019-04-04
- Primary completion
- 2019-10-29
- Completion
- 2019-10-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atovaquone | Small molecule | 1000 mg | — |
| Subject | Proguanil | Small molecule | 400 mg | — |
| Subject | amodiaquine | Other / unclassified | 612 mg | — |