Comparative clinical study of the pharmacokinetics and bioequivalence of the combined drug Mioreol and the combined use of mono-drugs containing donepezil and memantine

With no approved vaccine or treatment for dengue, and given preclinical evidence of antiviral activity, a tablet formulation of an aqueous plant extract (AQCH) was investigated as a potential treatment for dengue and COVID-19. This dose-escalation study in 60 healthy adults evaluated the safety and pharmacokinetics of AQCH tablets across five ascending doses, with the bioactive marker sinococuline quantified by LC-MS/MS and pharmacokinetic parameters (via Phoenix and SAS software) assessed after 9 days of dosing. The formulation was well tolerated at all doses, with sinococuline exposure showing linear pharmacokinetics up to 600 mg and saturation kinetics at 800 mg, and steady state achieved within three days. These pharmacokinetic findings will help inform further dose optimization of AQCH tablets for dengue and COVID-19 treatment.