Pharmacokinetics of a Novel Piperaquine Dispersible Granules Formulation Under Fasting and Various Fed Conditions Versus Piperaquine Tablets When Fasted in Healthy Tanzanian Adults: A Randomized, Phase I Study.

ABSTRACT: Piperaquine tetraphosphate (PQP), a long-acting antimalarial, is being considered in a combination for chemoprevention. Dihydroartemisinin-piperaquine tablets (hard and dispersible) approved for the treatment of acute uncomplicated malaria should be administered in a fasted state, as PQP bioavailability increases with food. A new taste-masked dispersible granules PQP formulation aims to minimize the impact of food on drug exposure. This randomized, open label, parallel group, Phase I pilot study was conducted between 24th July 2023, and 3rd January 2024, at the Ifakara Health Institute, Bagamoyo, Tanzania in 60 healthy African adults (five cohorts of 12). Single-dose pharmacokinetics and relative systemic exposure of the oral PQP dispersible granules formulation prototype (320 mg) was comp

SUBMITTER: Milando FA 

PROVIDER: S-EPMC11794830 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature