Effect of food on the pharmacokinetics of omeprazole, pantoprazole and rabeprazole
EntityUAM. Departamento de Farmacología; Instituto de Investigación Sanitaria Hospital Universitario de La Princesa (IIS-IP)
10.1186/s40360-020-00433-2BMC Pharmacology and Toxicology 21.1 (2020): 54
Funded byThe analysis, interpretation of data and the manuscript writing was partially funded by Fundación Teófilo Hernando, a nonprofit foundation linked to Universidad Autónoma de Madrid
SubjectsFood; Omeprazole; Pantoprazole; Pharmacokinetics; Proton pump inhibitors; Rabeprazole; Farmacia
Rights© 2020 The authors.
Esta obra está bajo una Licencia Creative Commons Atribución 4.0 Internacional.
Background: The pharmacokinetics of proton pump inhibitors (PPIs) may be affected by food intake. We aimed to evaluate the effect of food on the pharmacokinetics of omeprazole, rabeprazole, and pantoprazole. Setting: The study population comprised 186 healthy volunteers participating in 6 bioequivalence clinical trials. Method: Subjects were evaluated to determine the effect of a high-fat breakfast on the pharmacokinetics of omeprazole (n = 36), rabeprazole (n = 69), and pantoprazole (n = 81). Main outcome measure: Drug plasma concentrations were measured using high-performance liquid chromatography coupled to mass spectrometry. Results: Food affected the pharmacokinetics of omeprazole (increased Tmax and decreased AUC and Cmax), pantoprazole (increased Tmax and decreased AUC), and rabeprazole (increased Tmax, Cmax and half-life). Food increased variability in Tmax for all 3 drugs, delaying absorption around 3 to 4 h and until 20 h in some subjects. Conclusion: As food delays the absorption of PPIs and increases their variability, it would be better to administer these drugs under fasting conditions. Trial registration: European Union Drug Regulating Authorities Clinical Trials Database: EudraCT: 2004-003863-59 (registration date 05/MAR/2004), EudraCT 2006-001162-17 (registration date 17-MAR-2006), EudraCT: 2007-002489-37 (registration date 12-JUN-2007), EudraCT: 2007-002490-31 (registration date 12-JUN-2007), EudraCT: 2010-024029-19 (registration date 23-NOV-2010).
Google Scholar:Ochoa Mazarro, María Dolores - Román, Manuel - Cabaleiro, Teresa - Saiz-Rodríguez, Miriam - Mejía, Gina - Abad Santos, Francisco
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