Beschreibung:
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Aims</jats:italic> The aim of this study was to examine the bioequivalence between a single oral dose of digoxin administered alone and with a coadministration of macrogol 4000 (a laxative polymer) in 18 healthy volunteers.</jats:p><jats:p> <jats:italic>
Methods This was an open, randomised, two‐way cross‐over study, with a single dose oral administration of 0.5 mg digoxin administered alone or in combination with macrogol 4000, 20 g day<jats:sup>−1</jats:sup></jats:italic> during 8 days. Pharmacokinetics of digoxin, heart rate and PR ECG interval at rest were assessed.</jats:p><jats:p> <jats:italic>
Results Macrogol 4000 coadministration was associated with a 30% decrease of digoxin AUC and a 40% decrease in its C<jats:sub>max</jats:sub> (P<0.05). Digoxin t<jats:sub>max</jats:sub> and t<jats:sub>1/2,z</jats:sub></jats:italic> were not significantly altered. Heart rate and PR interval did not differ during the two therapeutic sequences, digoxin alone and digoxin in combination.</jats:p><jats:p> <jats:italic>
Conclusions</jats:italic> Macrogol 4000 coadministration interacts with single‐dose digoxin pharmacokinetics. This is most likely due to a reduction of the intestinal absorption of digoxin. However, there was no consequence of this interaction on heart rate and AV conduction.</jats:p>