Table 2.
Plasma oxymorphone pharmacokinetic parameters
| Parameter | Treatment | |||||
|---|---|---|---|---|---|---|
| 5 mg, Fasted (n = 28) | 40 mg, Fasted (n = 31) | 40 mg, Fed (n = 30) | ||||
| Oxy-ER | Oxy-CRF | Oxy-ER | Oxy-CRF | Oxy-ER | Oxy-CRF | |
| AUC0–t, ng · h/mL Mean ± SD | 5.05 ± 1.55 | 5.29 ± 1.52 | 31.51 ± 10.95 | 31.23 ± 10.33 | 50.16 ± 14.91 | 49.01 ± 14.03 |
| %CV | 30.7 | 28.7 | 34.7 | 33.1 | 29.7 | 28.6 |
| AUC0–inf, ng · h/mL Mean ± SD | ND | ND | 32.99 ± 11.58 | 32.65 ± 10.92 | 52.29 ± 15.98 | 50.95 ± 14.63 |
| %CV | 35.1 | 33.4 | 30.6 | 28.7 | ||
| Cmax, ng/mL Mean ± SD | 0.38 ± 0.11 | 0.37 ± 0.12 | 2.37 ± 1.20 | 2.41 ± 0.94 | 5.87 ± 1.99 | 5.63 ± 2.26 |
| %CV | 30.5 | 31.7 | 50.6 | 38.9 | 33.9 | 40.1 |
| Median tmax, h | 6.0 | 5.0 | 3.0 | 5.0 | 3.5 | 5.0 |
| Range | 1.0–12.0 | 1.0–16.0 | 0.5–12.0 | 0.5–12.0 | 1.0–6.0 | 1.0–10.0 |
| Mean ± SD t1/2, ha | ND | ND | 10.0 ± 2.5 | 9.9 ± 2.7 | 10.5 ± 4.1 | 10.3 ± 3.6 |
| %CV | 25.5 | 26.9 | 39.3 | 35.2 | ||
a
Note: Not evaluated because monoexponential elimination was not evident in most cases.
Abbreviations: AUC0–inf, area under the concentration versus time curve from time 0 to infinity; AUC0–t, AUC from time 0 to the last measured concentration; Cmax, maximum plasma concentration; CV, coefficient of variation; ND, not determined; Oxy-CRF, crush-resistant oxymorphone extended release; Oxy-ER, oxymorphone extended release; t1/2, terminal half-life; tmax, time to Cmax; SD, standard deviation.