Table 3.
Main pharmacokinetic parameters (mean ± SEM) for 2-aminoindane in young healthy males (n = 12 per group) after different multiple oral doses of CHF3381 given twice daily
| 100 mg twice daily | 200 mg twice daily | 400 mg twice daily | ||||
|---|---|---|---|---|---|---|
| Pharmacokinetic parameter | Day 1 | Day 14 | Day 1 | Day 14 | Day 1 | Day 14* |
| Cmax (ng ml−1) | 17.7 ± 0.7 | 56.0 ± 3.3 | 41.91 ± 4.0 | 134.4 ± 10.5 | 77.7 ± 4.2 | 304.3 ± 21.0 |
| tmax (h)# | 7.0 (4.0–10.0) | 3.0 (2.0–8.0) | 8.0 (6.0–12.0) | 4.0 (2.0–8.0) | 8.0 (4.0–12.0) | 4.0 (2.0–8.0) |
| AUC(0.12 h) (ng ml−1 h) | 152 ± 4 | 565 ± 31 | 326 ± 16 | 1361 ± 07 | 665 ± 30 | 3136 ± 10 |
| t½ (h) | 14.2 ± 0.6 | 12.7 ± 0.7 | 13.9 ± 0.8 | |||
| R | 3.72 ± 0.18 | 4.18 ± 0.27 | 4.82 ± 0.27 | |||
| AU (%) | 6.8 ± 0.4 | 5.9 ± 0.8 | 6.9 ± 0.8 | |||
| CLR (ml min−1) | 120.0 ± 7.5 | 88.3 ± 12.3 | 88.9 ± 10.5 | |||
R = accumulation ratio. AU = percent of dose recovered in urine in the 0–12 h period.
#
Median and range.
*
n = 11.