Effect of food on the pharmacokinetics of omeprazole, pantoprazole and rabeprazole.
BMC Pharmacol Toxicol
; 21(1): 54, 2020 07 25.
Article
en En
| MEDLINE
| ID: mdl-32711578
ABSTRACT
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 OUTCOMEMEASURE:
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).Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Omeprazol
/
Grasas de la Dieta
/
Interacciones Alimento-Droga
/
Inhibidores de la Bomba de Protones
/
Rabeprazol
/
Pantoprazol
/
Antiulcerosos
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
BMC Pharmacol Toxicol
Año:
2020
Tipo del documento:
Article