Table 4.
Pharmacokinetic parameters (summary statistics) in multiple-dose study
| Cohort (dosage level) | n | Evaluation date | AUClast (ng·h/ml) |
Cmax (ng/ml) |
|---|---|---|---|---|
| Mean ± SD | ||||
| M1 (2.5 mg) | 8 | Day 1a | 600 ± 133 | 151 ± 56 |
| 7 | Day 27b | 1830 ± 380 | 168 ± 24 | |
| 7 | Day 27/day 1 | 3.05 (2.91–3.19)c | 1.18 (0.86–1.62)c | |
| M2 (5 mg) | 8 | Day 1 | 1200 ± 560 | 315 ± 89 |
| 8 | Day 27 | 3860 ± 1840 | 356 ± 143 | |
| 8 | Day 27/day 1 | 3.20 (2.87–3.57)c | 1.09 (0.90–1.32)c | |
AUClast, area under the curve from time 0 to last time point with quantifiable concentration before the next hemodialysis; M, multiple-dose.
a
First administration day of multiple-dose part of study.
b
Last administration day of multiple-dose part of study.
c
Geometric mean (95% confidence interval).