Table 4.
PK results | ||||||
---|---|---|---|---|---|---|
Reference | Population | Administration | Dose | tmax (h) | Cmax (ng ml−1) | AUC (ng ml−1 h) |
Leliboux et al. [13] | Healthy young | Oral/R | 50 mg twice daily | 0.75 | 271 | 1029 |
Healthy elderly | Oral/R | 50 mg twice daily | 0.75 | 244 | 869 | |
Groenveld et al. [14] | Patients | Oral/R | 50 mg twice daily | – | 231 | 48.7* |
Leliboux et al. [7] | Healthy | Oral/S | 25 mg | 1.1 | 52 | 207 |
Healthy | Oral/S | 50 mg | 0.9 | 180 | 537 | |
Healthy | Oral/S | 100 mg | 1.6 | 282 | 1195 | |
Healthy | Oral/R | 25 mg | 0.8 | 77 | 295 | |
Healthy | Oral/R | 50 mg | 0.8 | 137 | 654 | |
Healthy | Oral/R | 100 mg | 1.3 | 357 | 1483 | |
Groenveld et al. [15] | Patients | Oral/R | 50 mg twice daily | – | 183 | 1473 |
AUC, area under the curve; tmax time to reach maximal concentration; Cmax maximal concentration; λz elimination constant; t1/2 elimination half-life; S, Single dose study; R: Repeated dose study.
AUC normalized to weight.