Background: An oral triple therapy using sucralfate instead of a bismuth to eradicate Helicobacter pylori has yielded worse results than those obtained with conventional oral triple therapies. To date, the effect of sucralfate on the pharmacokinetics of nitroimidazolic compounds used in triple therapy such as with metronidazole is unknown. The aim of this study was to investigate the effect of a 5-day administration period of sucralfate (2 g b.i.d.) on metronidazole pharmacokinetics.
Methods: Fourteen healthy male volunteers were selected. The study had an open randomized 2-period crossover design with a 14-day washout period between the phases. The plasma concentration of metronidazole and its hydroxy-metabolite were measured by reverse-phase HPLC with ultraviolet detection.
Results: No statistically significant difference was observed in any of the pharmacokinetic parameters studied in the absence and presence of sucralfate.
Conclusion: Our results clearly indicate that short-term treatment with sucralfate in healthy volunteers does not alter the extent or the rate of metronidazole absorption, and does not affect metronidazole clearance.