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Artesunate amodiaquine

Manufactured by Sanofi
Sourced in Switzerland, France

Artesunate–amodiaquine is a combination of two anti-malarial drugs, artesunate and amodiaquine. It is primarily used for the treatment of uncomplicated Plasmodium falciparum malaria.

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2 protocols using artesunate amodiaquine

1

Comparing Malaria Treatment Regimens

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We assigned eligible participants to repeated therapy with either pyronaridine–artesunate (Shin Poong Pharmaceutical, Ansan, South Korea) or dihydroartemisinin–piperaquine (Alfasigma SpA, Pomezia, [RM], Italy) versus either artemether–lumefantrine (Novartis Pharma AG, Basel, Switzerland) or artesunate–amodiaquine (Sanofi, Paris, France), depending on study centre. There was no direct comparison between pyronaridine–artesunate and dihydroartemisinin–piperaquine. This was an open label study, although microscopists doing the parasitological assessments were masked to treatment allocation. A computer-generated randomisation list for each site within each country was used. To minimise the risk of investigators guessing treatment allocation, when there were two treatments to allocate the block size was randomly two or four and when there were three treatments to allocate the block size was randomly three or six. The University of Bamako data management team enclosed the randomisation code containing the study arm in sealed, opaque, sequentially numbered envelopes. The site investigator opened the envelopes in order and assigned treatment accordingly. Because recruitment criteria for age and bodyweight differed between treatments, a separate randomisation list was generated for each experimental drug.
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2

In vitro and Animal Studies of Antimalarial Drugs

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In vitro studies. The antimalarial artesunate-amodiaquine (ASAQ Winthrop) (Sanofi-Aventis, Gentilly Cedex, France) was solubilized by crushing the tablets and resuspending in dimethyl sulfoxide to prepare a solution with the AQ component at a concentration of 100 mM. The compounds, amodiaquine dihydrochloride dihydrate (#A2799), artesunate (#A3731), and dihydroartemisinin (#D7439) were purchased from Sigma-Aldrich (Saint Louis, MO). N-desethylamodiaquine hydrochloride (#Sc-212178) was obtained from Santa Cruz Biotechnology (Dallas, TX). Drugs were prepared as 100 mM stocks in dimethyl sulfoxide. Animal studies. Source, formulation, and preparation of amodiaquine hydrochloride was the same for the PK and the efficacy studies. Amodiaquine hydrochloride was obtained from US Pharmacopeia (Rockville, MD; Cat. 1031004; Lot J01144) and a 4 mg/mL AQ (free base) solution was prepared in Sterile Water for Injection (USP).
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