Table 5.
Pharmacokinetic parameters for voclosporin after oral administration of voclosporin 0.4 mg kg−1 every 12 h alone and with verapamil 80 mg every 8 h
| Parameter | Voclosporin alone | Voclosporin + verapamil | |
|---|---|---|---|
| (n = 20) | (n = 20) | ||
| Voclosporin | Voclosporin | Verapamil | |
| Tmax (h) | 1.63 | 2.00 | 1.00 |
| Cmax (ng ml−1) | 105 ± 30.9 | 219 ± 64.1 | 268 ± 95.4 |
| GMR % (90% CI) | – | 207.76 (189.21–228.14) | – |
| AUC(0–12)* (h ng ml−1) | 434 ± 158 | 1165 ± 390 | 1164 ± 358 |
| GMR % (90% CI) | – | 271.15 (255.97–287.24) | – |
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 voclosporin alone) based on analysis of natural log-transformed data; Tmax, time to reach maximal concentration.
*
AUC(0–8) for verapamil data.