Lack of interaction between pantoprazole and ethanol - A randomised, double-blind, placebo-controlled study in healthy volunteers

Objective: To assess the effect of the proton pump inhibitor pantoprazole o n 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, rand omised, crossover study. Participants received placebo and pantoprazole 40m g, 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 we re measured over a period of 8 hours and the following pharmacokinetic para meters determined: (i) area under the blood ethanol concentration versus ti me curve (AUC), (ii) maximum concentration of ethanol in blood (C-max) and (iii) elimination rate of ethanol (k(el)). Results: The mean values for the three pharmacokinetic parameters of ethano l were similar during the pantoprazole and placebo study periods: AUC 112.7 vs 111.3 mg/dl.h, C-max 43.5 versus 42.7 mg/dl and k(el) 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 eq uivalence range. Conclusions: A therapeutic dose of pantoprazole 40mg did not alter the abso rption or the elimination rate of a moderate dose of ethanol in healthy ind ividuals. Thus, it would be expected that in patients with gastric acid-rel ated diseases such as peptic ulcer or gastro-oesophageal reflux disease, pa ntoprazole therapy would not cause elevation of blood ethanol concentration after moderate social drinking.