86337
document
Lack of interaction between pantoprazole and digoxin at therapeutic doses in man . Substituted benzimidazole inhibitors of the gastric H+/K+ATPase may interact with the cytochrome P450 enzyme system and alter the pharmacokinetics of coadministered drugs . On the other hand , changes in intragastric pH might alter the absorption of other drugs . The primary aim of the present study was to determine whether pantoprazole modifies the steady-state serum concentrations of orally administered digoxin . Secondary aims were the influence of digoxin on the pharmacokinetics of pantoprazole as well as safety and tolerability . Eighteen healthy volunteers received a single oral dose of pantoprazole ( 40 mg ) and serum concentrations were determined . Three to 10 days later , subjects received in a single-blind , randomized , crossover fashion oral beta-acetyldigoxin ( 0.2 mg ) twice daily and concomitant oral pantoprazole ( 40 mg ) or placebo once daily for 5 days . Serum concentrations of pantoprazole and digoxin were determined on day 5 . Primary characteristics for confirmative assessment of no interaction were AUC and Cmax of digoxin . Lack of interaction in the sense of equivalence was concluded for both digoxin ( with and without pantoprazole ) and pantoprazole ( with and without digoxin ) as the 90 % -confidence intervals of the respective AUC- and Cmax-ratios were within the equivalence range of 0.8-1.25 . Pantoprazole did not influence the characteristic ECG modifications ( T-wave ) caused by digoxin . Both drugs were well tolerated and no adverse events or clinically relevant alterations in vital signs or clinical laboratory parameters were observed during treatment . In conclusion , pantoprazole and digoxin may be administered concomitantly without the need for dose adjustment .
86338
Intervention_Pharmacological
pantoprazole and digoxin
86339
Intervention_Pharmacological
Substituted benzimidazole inhibitors
86340
Intervention_Pharmacological
pantoprazole
86341
Intervention_Pharmacological
digoxin
86342
Intervention_Pharmacological
digoxin
86343
Intervention_Pharmacological
pantoprazole
86344
Intervention_Pharmacological
oral dose of pantoprazole ( 40 mg )
86345
Intervention_Pharmacological
beta-acetyldigoxin
86346
Intervention_Pharmacological
concomitant oral pantoprazole
86347
Intervention_Control
placebo
86348
Intervention_Pharmacological
pantoprazole
86349
Intervention_Pharmacological
digoxin
86350
Intervention_Pharmacological
digoxin
86351
Intervention_Pharmacological
pantoprazole
86352
Intervention_Pharmacological
pantoprazole
86353
Intervention_Pharmacological
digoxin
86354
Intervention_Pharmacological
Pantoprazole
86355
Intervention_Pharmacological
pantoprazole
86356
Intervention_Pharmacological
digoxin
86357
Outcome_Other
AUC and Cmax of digoxin .
86358
Outcome_Other
AUC- and Cmax-ratios
86359
Outcome_Other
tolerated
86360
Outcome_Adverse-effects
adverse events
86361
Participant_Condition
in
86362
Participant_Sex
man
86363
Participant_Condition
.
86364
Participant_Sample-size
Eighteen