SPAP-BEDDI

INTERVENTION: Reference treatment with SP and AP and loose combination of both Test treatment fixed dose combination of SP and AP CONDITION: ; Malaria Malaria PRIMARY OUTCOME: ‐ Interaction (Periods 1–3): Geometric mean ratios (90% CI) for AUC0–? and Cmax; ‐ Bioequivalence (Periods 3–4): Comparison of AUC (AUC0–72? for sulfadoxine, pyrimethamine, pyronaridine, and AUC0–? for artesunate/DHA), and Cmax for each component; Bioequivalence = 90% CI for the geometric mean ratios (test/reference) of AUC and Cmax for all four components fall within 80–125% SECONDARY OUTCOME: ‐ incidence, severity, and timing of adverse events ; ‐ changes from baseline in vital signs and clinical laboratory parameters ; ‐ comparison of t???, t½, CL/F, Vz/F between regimens ; ‐ assessment of absorption, metabolism, and elimination of individual compounds INCLUSION CRITERIA: ‐ Adults aged 18–55 years. ‐ Agreement of participants of childbearing potential to use effective contraception during the study. ‐ BMI within 18–30 kg/m². ‐ Medically healthy on history, physical examination, vital signs, and routine laboratory tests as per local laboratory reference ranges. ‐ Ability and willingness to comply with all study procedures and provision of written informed consent. ‐ Willingness to reside in the study area for the upcoming =8 months.