Table 2 Pharmacokinetic estimates under fed and fasted conditions in study completers of studies 1 and 2
Drug/Parameter, geometric mean (SD) | Study 1 (2 tablets IR/ER HB/APAP; n = 40a) | Study 2 (3 tablets IR/ER HB/APAP; n = 21b) | ||||
|---|---|---|---|---|---|---|
High-fat meal | Low-fat meal | Fasted | High-fat meal | Low-fat meal | Fasted | |
Hydrocodone | ||||||
AUC0–t, ng•h/mL | 301.50 (52.81) | 299.72 (57.01) | 280.10 (58.80) | 392.61 (98.89) | 401.63 (99.51) | 361.21 (83.32) |
AUC0–inf, ng•h/mL | 303.66 (53.13) | 301.95 (57.83) | 282.94 (59.86) | 395.03 (99.82) | 404.25 (100.35) | 365.70 (85.51) |
Cmax, ng/mL | 21.66 (4.88) | 23.09 (3.79) | 20.33 (4.33) | 28.04 (6.29) | 29.58 (6.69) | 25.42 (6.15) |
tmax, hc | 6.00 (2.00–11.00) | 4.00 (2.00–7.00) | 4.00 (2.00–7.00) | 4.00 (1.00–12.00) | 4.00 (2.00–12.00) | 3.00 (1.00–5.00) |
tlag, hc | 0.00 (0.00–1.07) | 0.25 (0.00–0.75) | 0.00 (0.00–0.50) | 0.00 (0.00–0.75) | 0.25 (0.00–0.50) | 0.00 (0.00–0.25) |
t½, h | 5.58 (0.85) | 5.85 (1.00) | 6.43 (1.11) | 5.25 (0.85) | 5.54 (0.78) | 6.35 (1.52) |
APAP | ||||||
AUC0–t, ng•h/mL | 33,210.39 (10,402.75) | 32,415.11 (9586.52) | 32,149.34 (9431.97) | 46,656.25 (12,228.35) | 47,730.72 (12,238.72) | 47,702.26 (13,034.74) |
AUC0–inf, ng•h/mL | 34,689.91 (10,672.37) | 34,092.21 (9949.21) | 34,803.59 (9635.34) | 48,227.95 (12,104.97) | 50,010.40 (12,223.51) | 51,623.79 (11,493.91) |
Cmax, ng/mL | 4317.00 (1185.08) | 4122.25 (877.19) | 5307.00 (1419.43) | 6250.95 (1646.83) | 5733.33 (1389.04) | 7740.48 (2488.56) |
tmax, hc | 2.00 (0.25–6.05) | 2.00 (0.75–7.00) | 0.75 (0.25–5.00) | 1.00 (0.50–3.00) | 3.00 (0.50–8.00) | 0.75 (0.50–2.00) |
tlag, hc | 0.00 (0.00–0.63) | 0.25 (0.00–0.50) | 0.00 (0.00–0.25) | 0.00 (0.00–0.25) | 0.00 (0.00–0.50) | 0.00 (0.00–0.25) |
t½, h | 5.37 (2.02) | 5.68 (1.68) | 7.37 (2.77) | 5.80 (1.72) | 7.07 (2.53) | 8.13 (1.90) |