Table 6.
Pharmacokinetic parameters for digoxin after oral administration of digoxin 0.25 mg once daily alone and with voclosporin 0.4 mg kg−1 every 12 h
| Parameter | Digoxin alone | Digoxin + voclosporin | |
|---|---|---|---|
| (n = 23) | (n = 23) | ||
| Digoxin | Digoxin | Voclosporin | |
| Tmax (h) | 1.00 | 1.00 | 1.55 |
| Cmax (pg ml−1)* | 1689 ± 317 | 2566 ± 624 | 124 ± 38.7 |
| GMR % (90% CI) | – | 150.93 (139.67–163.10) | – |
| AUC(0–24)† (h pg ml−1) | 15 651 ± 3012 | 19 514 ± 3575 | 497 ± 188 |
| GMR % (90% CI) | – | 124.88 (119.39–130.62) | – |
| Ue(0–24) (mg) | 0.12 ± 0.03 | 0.14 ± 0.04 | – |
| GMR % (90% CI) | – | 120.54 (107.94–134.60) | – |
| Renal clearance (ml min−1) | 127 ± 36.6 | 121 ± 32.8 | – |
Values are shown as means ± SD except Tmax, for which the median is reported. Abbreviations are as follows: AUC, area under the curve; CI, confidence interval; Cmax, maximal concentration; GMR, geometric least squares mean ratio (comparison to digoxin alone) based on analysis of natural log-transformed data; Tmax, time to reach maximal concentration, Ue, urinary excretion.
*
Values are in nanograms per millilitre for voclosporin data.
†
AUC(0–12) for voclosporin data.