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\begin{document}

\title{High-fat breakfast increases bioavailability of albendazole compared to
light breakfast: single-dose study in healthy subjects}



\author[1]{Dolores Ochoa}%
\author[1]{Miriam Saiz-Rodríguez}%
\author[1]{Esperanza González-Rojano}%
\author[1]{Manuel Román}%
\author[2]{Sergio Sánchez-Rojas }%
\author[1]{Aneta Wojnicz}%
\author[2]{Ana Ruiz-Nuño}%
\author[2]{Alfredo García-Arieta}%
\author[3]{Francisco Abad-Santos}%
\affil[1]{Hospital Universitario de la Princesa}%
\affil[2]{Affiliation not available}%
\affil[3]{Service of Clinical Pharmacology, Hospital Universitario de la Princesa}%


\vspace{-1em}



  
  \date{June 15, 2024}


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\begin{abstract}
Background -- Albendazole is a benzoimidazole carbamate drug with
anthelmintic and antiprotozoal activity against intestinal and tissue
parasites. It has been described that the administration with meals
increases albendazole absorption. Objective -- Our aim was to compare
the systemic exposure in healthy volunteers of two albendazole
formulations after a single oral dose under fed conditions and to
evaluate the effect of breakfast composition on its bioavailability.
Methods -- 12 healthy volunteers were included in a crossover, open,
randomized comparative bioavailability trial including two stages.
Single oral doses of 400 mg albendazole were administered under fed
conditions (a light breakfast in first stage and a high-fat breakfast in
the second) separated by 7-day washout periods. Plasma albendazole and
albendazole sulfoxide concentrations were measured by HPLC-MS/MS.
Results -- Albendazole absorption was clearly influenced by the meal
composition. A high-fat breakfast increased albendazole and albendazole
sulfoxide area under the concentration-time curve (AUC) and maximum
concentration (Cmax) by double compared to a light breakfast. The
bioavailability of the two formulations was very similar, although the
sample size was not sufficient to demonstrate bioequivalence because the
intra-individual variability of albendazole was approximately 60\%.
Conclusions -- The higher albendazole and albendazole sulfoxide levels
when administered with a high-fat meal could be of importance in
clinical practice. Since albendazole labelling recommends its
administration with meals, it is necessary to insist the patient to take
it with a fatty meal so that the effectiveness of albendazole is not
compromised.%
\end{abstract}%



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