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Lack of Interaction between Pantoprazole and Ethanol

A Randomised, Double-Blind, Placebo-Controlled Study in Healthy Volunteers

  • Clinical Pharmacokinetics
  • Published:
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Abstract

Objective: To assess the effect of the proton pump inhibitor pantoprazole on the pharmacokinetics of ethanol.

Study Participants: Nonalcoholic, healthy volunteers (four female, 12 male, age range 23 to 30 years).

Study Design and Methods: This was a placebo-controlled, double-blind, randomised, crossover study. Participants received placebo and pantoprazole 40mg, respectively, for 7 days each, separated by a 14-day washout period. On day 7 of each period, a moderate dose of ethanol (0.5 g/kg) was consumed 2 hours after administration of the study medication. Blood ethanol levels were measured over a period of 8 hours and the following pharmacokinetic parameters determined: (i) area under the blood ethanol concentration versus time curve (AUC), (ii) maximum concentration of ethanol in blood (Cmax), and (iii) elimination rate of ethanol (kel).

Results: The mean values for the three pharmacokinetic parameters of ethanol were similar during the pantoprazole and placebo study periods: AUC 112.7 vs 111.3 mg/dl·h, Cmax 43.5 versus 42.7 mg/dl and kel 12.3 versus 12.5 dl/h. The 90% confidence intervals for the ratio of these values (ethanol + pantoprazole : ethanol + placebo) were completely within the predefined equivalence range.

Conclusions: A therapeutic dose of pantoprazole 40mg did not alter the absorption or the elimination rate of a moderate dose of ethanol in healthy individuals. Thus, it would be expected that in patients with gastric acid-related diseases such as peptic ulcer or gastro-oesophageal reflux disease, pantoprazole therapy would not cause elevation of blood ethanol concentration after moderate social drinking.

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Acknowledgements

The authors thank Dr Kathy B. Thomas, Byk Gulden, Konstanz, Germany for useful suggestions during the preparation and editing of the manuscript. This study was supported by a grant from Byk Gulden, Konstanz, Germany.

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Authors and Affiliations

  1. Clinical Gastroenterology, Byk Gulden, Byk Gulden Strasse 2, D-78467, Konstanz, Germany

    H. Heinze & R. Fischer

  2. University Hospital of Heidelberg, Mannheim, Germany

    R. Pfützer, S. Teyssen & M. V. Singer

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  1. H. Heinze
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  2. R. Fischer
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  3. R. Pfützer
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  4. S. Teyssen
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  5. M. V. Singer
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Correspondence to H. Heinze.

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Heinze, H., Fischer, R., Pfützer, R. et al. Lack of Interaction between Pantoprazole and Ethanol. Clin. Drug Investig. 21, 345–351 (2001). https://doi.org/10.2165/00044011-200121050-00004

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