Safety and pharmacokinetic properties of a new formulation of parenteral artesunate in healthy Thai volunteers.

ABSTRACT:

Background

Parenteral artesunate is the first-line therapy for severe malaria. Artesunate, in its current formulation, must be prepared immediately before administration by first dissolving in sodium bicarbonate solution and then diluting in saline. A novel solvent for rapid and stable single step reconstitution of artesunate was recently developed showing improved solubility and stability. This study aimed to compare the safety and pharmacokinetic properties of the currently available and newly developed parenteral formulation of artesunate in healthy Thai volunteers.

Methods

This was an open-label, randomized, 4 periods, 4-treatments, 24-sequence, single-dose, cross-over study in 72 male and female healthy Thai volunteers. Frequent pharmacokinetic samples were collected in

SUBMITTER: Tarning J 

PROVIDER: S-EPMC11450984 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature