Bioavailability of dronedarone tablets administered with or without food in healthy participants.

ABSTRACT:

Study objective

There is inadequate awareness of the effect of food on the bioavailability of dronedarone. We report results from two phase 1 studies assessing the effect of food on dronedarone's bioavailability.

Design setting and participants

Study 1; single-center, open-label, randomized study in healthy adults (males and females). Study 2; single-center, open-label, randomized study in healthy males.

Interventions

Study 1; a single 400-mg oral dose of dronedarone (marketed formulation) in fed (high-fat [47.4 g] meal) and fasted states. Study 2; a single 800-mg oral dose of dronedarone (two 400-mg tablets) after fat-rich (37.3 g) and low-fat (5.3 g) meals, and after fasting.

Main outcome measures

Pharmacokinetic parameters including maximum plasma concentrat

SUBMITTER: Naccarelli GV 

PROVIDER: S-EPMC11305208 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature