Table 2. Pharmacokinetic parameters of oxycodone after single-dose administration of OOD and OTD.
| Parameter | Study 1 (fasting) | Study 2 (fed) | ||
|---|---|---|---|---|
| OOD | OTD | OOD | OTD | |
| AUC(0–t) (ng/mL×h)a | 90.63 [95.78] (39.81 – 181.40) |
76.47 [81.10] (39.08 – 197.35) |
90.80 [95.64] (36.97 – 156.43) |
88.36 [93.47] (37.17 – 158.45) |
| AUC(0–∞) (ng/mL×h)a | 99.85 [104.62] (48.06 – 193.83) |
84.04 [88.18] (50.18 – 203.64) |
98.51 [103.04] (45.43 – 161.93) |
96.91 [101.50] (48.75 – 171.95) |
| Residual area (%)b | 9.11 ± 4.689 (2.68 – 19.81) |
8.90 ± 4.503 (2.38 – 22.12) |
7.75 ± 3.642 (2.73 – 18.64) |
8.66 ± 5.242 (3.02 – 23.76) |
| AUC(0–12h) (ng/mL×h)a | NA | 27.90 [29.05] (15.23 – 55.74) |
NA | 35.88 [37.33] (19.08 – 55.52) |
| Cmax(0–t) (ng/mL)a | 5.05 [5.23] (2.76 – 8.43) | 4.92 [5.16] (2.61 – 9.97) | 5.68 [5.89] (2.31 – 8.53) | 5.65 [5.84] (2.94 – 9.68) |
| Cmax(0–12h) (ng/mL)a | NA | 3.87 [4.00] (2.22 – 7.77) | NA | 5.20 [5.38] (2.94 – 7.97) |
| tmax(0–t) (h)b | 9.6 ± 2.06 (4.0 – 12.0) | 14.1 ± 3.00 (1.5 – 15.5) | 9.1 ± 2.29 (7.0 – 14.0) | 9.1 ± 6.52 (1.0 – 16.5) |
| tmax(0–12h) (h)b | NA | 2.4 ± 1.04 (0.5 – 4.0) | NA | 2.8 ± 1.39 (1.0 – 6.0) |
| T1/2 (h)b | 7.1 ± 1.38 (4.5 – 10.3) | 6.3 ± 1.39 (3.8 – 10.8) | 6.5 ± 1.20 (4.3 – 9.3) | 6.3 ± 1.76 (3.9 – 12.0) |
aGeometric mean [arithmetic mean] (range); barithmetic mean ± standard deviation (range). OOD = oxycodone one daily; OTD = oxycodone twice daily; NA = not applicable.