Table 2.
Pharmacokinetic parameter | Valuea |
% MRb (90% CI) for treatment B/treatment A (fed vs fasted) | |
---|---|---|---|
Treatment A (fasted) | Treatment B (fed) | ||
Cmax (μg/ml) | 0.609 (38.6) | 0.633 (31.8) | 106.81 (97.56, 116.93) |
AUC0–t (μg · h/ml) | 5.470 (41.9) | 5.083 (34.6) | 97.08 (86.86, 108.50) |
AUC0–∞ (μg · h/ml) | 5.614 (40.7) | 5.267 (33.6) | 97.81 (87.89, 108.85) |
Tmax (h)b | 3.50 (2.50, 6) | 3.50 (2.50, 6) | NDc |
t1/2 (h)c | 5.37 (14.0) | 5.02 (13.1) | ND |
Cmax, AUC0–t, and AUC0–∞ are expressed as means (% CVs). Tmax is expressed as median (minimum, maximum). t1/2 is expressed as harmonic mean (% CV from pseudo-SD).
MR, mean ratio, based on the ratio of least-squares means.
ND, not determined.