Parameter, mean (SD) | OROS hydromorphone ER | IR Hydromorphone, fasted | |
---|---|---|---|
Fed | Fasted | ||
Study A | |||
No. of subjects | 29 | 30 | 30 |
AUC last , ng•h/mL | 45.9 (11.2) | 46.9 (13.8) | 43.9 (10.4) |
AUC 0-24 , ng•h/mL | 25.6 (6.5) | 25.7 (6.6) | 30 (7.6) |
C max , ng/mL | 1.8 (0.5) | 1.9 (0.5) | 3.6 (1.5) |
t max , ha | 16 (5.9–24.2) | 17.9 (6.0–24.2) | 18.5 (18.5–20.0) |
t ½,λ , h | 14.4 (4.1) | 14.4 (6.0) | 12.7 (3.4) |
Time ≥50% C max , h | 23.6 (8.0) | 21.6 (6.7) | 5.9 (4.1) |
Study B | |||
No. of subjects | 29 | 30 | |
AUC 0-24 , ng•h/mL | 57.6 (16.3) | 54.8 (14.8) | |
C maxss , ng/mL | 3.54 (0.96) | 5.28 (1.37) | |
C minss , ng/mL | 2.15 (0.87) | 1.47 (0.42) | |
t maxss , ha | 11.9 (5.9–24.2) | 7.0 (0.5–18.8) | |
Peak-to-trough fluctuation (flux), % | 60.5 (41.1) | 172 (57.6) | |
Time ≥50% C max , h | 20.5 (4.1) | 7.5 (4.8) |