ArticleAmerican heart journal plus : cardiology research and practice2024
Bioavailability of dronedarone tablets administered with or without food in healthy participants.
Article in American heart journal plus : cardiology research and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- New recommendations for rhythm control-What has changed in the 2023 ACC/AHA/ACCP/HRS and 2024 ESC guidelines for atrial fibrillation, and where does dronedarone fit in?American heart journal plus : cardiology research and practice · 2025Article
- Embryotoxicity analysis of anti-arrhythmia drugs amiodarone, dronedarone, and their metabolites using 3D gastruloid models.Reproductive toxicology (Elmsford, N.Y.) · 2025Article
- Determination of Dronedarone and Debutyldronedarone in Human Plasma by HPLC-UV.International journal of molecular sciences · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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 concentration (C Results: Twenty-six participants were included in Study 1 and nine in Study 2. In Study 1, administration of 400 mg dronedarone with a high-fat meal vs. fasted state resulted in 2.8-fold and 2.0-fold increases in C Conclusion: With food, the bioavailability of dronedarone is markedly increased. In clinical practice, dronedarone should be administered with a complete meal to maximize drug absorption.
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