Table 4.
Pharmacokinetic profile of naldemedine
| N | Cmax, ng/mL | Tmax, h | AUC0–τ, ng•h/mL | t½,z, h | |
|---|---|---|---|---|---|
| Naldemedine 0.1 mg/day | 4 | 1.15 (25.8) | 1.03 (1.00–1.97) | 9.677 (33.7) | 8.64 (16.4) |
| Naldemedine 0.2 mg/day | 4 | 2.00 (22.7) | 1.00 (1.00–1.03) | 16.94 (46.6) | 7.11 (28.7) |
| Naldemedine 0.4 mg/day | 4 | 4.03 (32.3) | 1.00 (1.00–1.08) | 31.72 (11.4) | 10.8 (31.5) |
All values are given as geometric mean (percentage coefficient of variation) other than Tmax, which is given as median (range). AUC0–τ, area under the concentration time curve from time 0 to the time point of the last measurable concentration in the dose interval.
Cmax = maximum observed plasma concentration Tmax = time to Cmax t½,z = apparent terminal elimination half-life