[Comparative study of the absolute bioavailability of four oral digoxin preparations (author's transl)].

In a randomized cross over study on 19 normal subjects the absolute bioavailability of four oral digoxin preparations (Digacin containing a silica gel matrix as preparation A and three other commercial digoxin tablet preparations, B, C and D) were investigated applying digoxin in a daily dose of 0.25 mg for 10 consecutive days. On day 8, 9 and 10, the serum digoxin concentration and the amount of digoxin excreted with 24-h urine were measured radioimmunologically. After i.v. administration the mean serum digoxin concentration amounted to 0.58 ng/ml. With oral administration preparation A achieved the highest concentration (0.51 ng/ml) and preparation C the lowest (0.42 ng/ml). Accordingly, after i.v. administration 118 microgram digoxin were excreted with the 24-h urine and 95 microgram after the oral preparation A and 73 microgram after preparation C, respectively. From the serum concentrations and the amount excreted with the urine the absolute bioavailability was calculated: 88.0 and 80.4%, respectively, for preparation A, 82.5 and 67.2% for preparation B, 72.7 and 61.8% for preparation C, 76.2 and 67.3% for preparation D.

RCT Entities:   Population Interventions Outcomes