Lack of pharmacokinetic interaction between oral pantoprazole and cisapride in healthy adults

Pantoprazole, an irreversible proton pump inhibitor may be administered with cisapride, a prokinetic agent. As increased cisapride concentrations may result in longer electrocardiogram (ECG QT(c) intervals, a crossover study was conducted in healthy subjects to evaluate the oral pharmacokinetic interaction between cisapride (20 mg) and pantoprazole (40 mg). After dosing, serial blood samples and 12-lead ECGs were collected, and cisapride plasma concentrations were quantitated. For cisapride alone, mean parameter values were the following: peak concentration (C-max), 56 ng/mL; time to C-max (t(max)), 1.7 hours; area under the concentration-time curve (AUC), 426 ng.h/mL; and terminal half-life (t(1/2)) 5.8 hours. Pantoprazole coadministration did not alter cisapride A UC or other pharmacokinetic parameters except for a slight 17% decrease in C-max, resulting in 90% confidence limits of 79% to 88%, which were marginally outside strict bioequivalence limits. In addition, cisapride did not affect ECG QT(c) intervals, with Or without pantoprazole. Therefore, no dosage adjustment is needed when pantoprazole and cisapride are coadministered. Journal of Clinical Pharmacology, 1999;39:945-950 (C) 1999 the American College of Clinical Pharmacology.