Phase I, single-center, randomized, open, parallel-group study for pharmacokinetic evaluation of artesunate-mefloquine use in combination with primaquine and tafenoquine (AMino Study)

Artesunate/mefloquine (ASMQ) has good efficacy, safety, and tolerability when used with primaquine (PQ) on the treatment of vivax malaria, falciparum malaria and mixed infections. However, there is little knowledge of the possible interactions of its use with PQ or TQ, recently approved by ANVISA. The results of this study will provide evidence for the option of using ASMQ with TQ and PQ, thereby subsidizing new research for universal treatment of malaria in the Amazon. This is a parallel, randomized, open, phase I clinical trial with the goal of characterizing the effect of interactions between ASMQ, TQ, and PQ on healthy volunteers over 18 years of age.