Parameter | BIIL 315 | BIIL 304 | ||
---|---|---|---|---|
gMean | gCV (%) | gMean | gCV (%) | |
All data were rounded to three significant digits; tmax and tmax,ss are given as median or ranges; * tmax,ss = 4 hours relative to drug intake at day 14; AUC0–6 h,ss = AUC 311.5–318 h,ss; NC = not calculated. | ||||
(A) Dose 25 mg | ||||
Cmax (ng/ml) | 11.1 | 48.8 | 0.995 | 48.6 |
Tmax (h) | 4.00 | 4.00–6.00 | 4.00 | 4.00–6.00* |
AUC0-6h (ng.h/ml) | 31.9 | 49.9 | 2.80 | 44.2 |
Cmax,ss (ng/ml) | 14.3 | 53.6 | 1.28 | 77.6 |
tmax,ss (h) | 316* | 314–318 | 316* | 316–318* |
AUC0–6 h,ss (ng.h/ml) | 44.9 | 75.9 | 3.17 | 70.8 |
Cpre,ss (ng/ml) | 0.506 | 108 | NC | NC |
(B) Dose 150 mg | ||||
Cmax (ng/ml) | 42.6 | 120 | 3.00 | 156 |
Tmax (h) | 4.00 | 1.50–6.00 | 4.00 | 2.00–6.00 |
AUC0–6 h (ng.h/ml) | 144 | 120 | 12.7 | 87.4 |
Cmax,ss (ng/ml) | 62.5 | 144 | 4.34 | 172 |
tmax,ss (h) | 316* | 314–318 | 316* | 314–318 |
AUC0–6 h,ss (ng·h/ml) | 211 | 131 | 18.0 | 103 |
Cpre,ss (ng/ml) | 2.44 | 84.9 | 0.213 | 42.9 |