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Clinical Trial
. 2020 Jul 25;21(1):54.
doi: 10.1186/s40360-020-00433-2.

Effect of food on the pharmacokinetics of omeprazole, pantoprazole and rabeprazole

Dolores Ochoa  1   2 , Manuel Román  1   2 , Teresa Cabaleiro  1   2 , Miriam Saiz-Rodríguez  1   3 , Gina Mejía  1   2 , Francisco Abad-Santos  4   5   6
Affiliations
Clinical Trial

Effect of food on the pharmacokinetics of omeprazole, pantoprazole and rabeprazole

Dolores Ochoa et al. BMC Pharmacol Toxicol. .

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 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).

Keywords: Food; Omeprazole; Pantoprazole; Pharmacokinetics; Proton pump inhibitors; Rabeprazole.

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Conflict of interest statement

F.A.S. and D.O. have been consultants or investigators in clinical trials sponsored by the following pharmaceutical companies: Abbott, Alter, Chemo, Cinfa, FAES, Farmalíder, Ferrer, GlaxoSmithKline, Galenicum, Gilead, Italfarmaco, Janssen-Cilag, Kern, Normon, Novartis, Servier, Silverpharma, Teva and Zambon. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Mean plasma concentration-time profiles of (a) pantoprazole, (b) rabeprazole and (c) omeprazole, when administered under fed and fasting conditions
Fig. 2
Fig. 2
Differences in PPI Tmax (a) and AUC (b) when administered under fed and fasting conditions. ***p < 0.001. Bars represented as mean and standard deviation
See this image and copyright information in PMC

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