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Table 1 Key clinical studies

From: The story of artesunate–mefloquine (ASMQ), innovative partnerships in drug development: case study

Country Study type Phase n Primary objective Major findings
Thailand HNV, PK and tolerability 1 24 PK and bio-availability of AS and MQ; administered separately and as a coformulation to healthy volunteers and patients No difference was seen in the bio-equivalence of MQ in the two formulations; although a difference was seen for AS/DHA, this was not concluded to be clinically relevant[20]
PK, efficacy and safety 2 50 Population PK model of new dosage regime of MQ with AS in loose combination over three days Splitting the 25 mg/kg dose of MQ into three doses of 8 mg/kg improved oral bio-availability compared to the conventional split-dose regimen results. New regimen was well tolerated and with an equivalent therapeutic response[21]
PK, efficacy and safety 2b 50 Safety and PK of ASMQ FDC vs non-fixed AS+MQ against multi-drug resistant falciparum malaria in adults FDC well-tolerated with broadly similar PK profiles to non-fixed AS plus MQ[22]. The observed slowing of heart rate was best explained by malaria resolution[23]
Efficacy and safety 3 500 ASMQ FDC with separate tablets in adults and children with uncomplicated multidrug-resistant falciparum malaria Cure rates were 91.9% for the FDC after 63 days, with a lower incidence of vomiting compared to those in the loose tablets group[24]
Myanmar Competitive Effectiveness 4 808 Effectiveness of five artemisinin combination regimens with or without PQ in uncomplicated falciparum malaria ASMQ provided the greatest post-treatment suppression of malaria after 63 days, with the addition of PQ substantially reducing transmission potential of malaria[25]
India Efficacy and safety 3 77 PCR corrected cure rate of ASMQ FDC in adult patients with uncomplicated falciparum malaria Mean parasite clearance time of 48 hours
Brazil Intervention study: PK Efficacy and safety 3b/4 23,845 Effectiveness of ASMQ FDC in reducing malaria transmission in the Juruá valley Early detection of malaria and treatment with ASMQ FDC was feasible and efficacious, significantly reduced the incidence and morbidity of falciparum malaria[26]