Table 3 Geometric LS mean ratios in study completers in studies 1 and 2
Drug/Parameter, % (90 % CI) | Study 1 (2 tablets IR/ER HB/APAP; n = 40a) | Study 2 (3 tablets IR/ER HB/APAP; n = 21b) | ||||
|---|---|---|---|---|---|---|
High-fat meal/Fasted | Low-fat meal/Fasted | High-fat meal/Low-fat meal | High-fat meal/Fasted | Low-fat meal/Fasted | High-fat meal/Low-fat meal | |
Hydrocodone | ||||||
AUC0–t, ng•h/mL | 108.40 (104.44–112.51) | 107.45 (103.53–111.52) | 100.89 (97.22–104.69) | 109.32 (105.53–113.25) | 111.63 (107.83–115.55) | 97.93 (94.67–101.32) |
AUC0–inf, ng•h/mL | 108.11 (104.14–112.24) | 107.17 (103.23–111.26) | 100.88 (97.19–104.72) | 108.64 (104.87–112.54) | 111.01 (107.24–114.92) | 97.86 (94.60–101.24) |
Cmax, ng/mL | 106.66 (100.54–113.15) | 114.75 (108.16–121.73) | 92.95 (87.64–98.59) | 114.71 (106.45–123.60) | 119.27 (110.86–128.33) | 96.17 (89.50–103.33) |
APAP | ||||||
AUC0–t, ng•h/mL | 102.70 (100.05–105.42) | 100.74 (98.15–103.41) | 101.94 (99.32–104.63) | 101.19 (95.65–107.05) | 102.36 (96.87–108.16) | 98.86 (93.65–104.36) |
AUC0–inf, ng•h/mL) | 100.32 (97.71–103.01) | 98.66 (96.09–101.30) | 101.69 (99.04–104.40) | 98.30 (92.92–103.99) | 101.64 (96.22–107.36) | 96.72 (91.71–102.00) |
Cmax, ng/mL | 80.49 (75.44–85.88) | 78.10 (73.20–83.33) | 103.06 (96.62–109.93) | 86.86 (77.33–97.55) | 78.68 (70.23–88.16) | 110.39 (98.72–123.43) |