Table 5.
Bioequivalence data: systemic plasma 6-OH-oxymorphone exposure
| Parameter | Ratio of least squares mean, Oxy-CRF/Oxy-ER | 90% CI |
|---|---|---|
| 5 mg, fasted | ||
| AUC0–t, ng · h/mL | 1.01 | 0.95–1.07 |
| Cmax, ng/mL | 0.80 | 0.75–0.86 |
| 40 mg, fasted | ||
| AUC0–t, ng · h/mL | 0.99 | 0.94–1.04 |
| AUC0–inf, ng · h/mL | 1.01 | 0.95–1.08 |
| Cmax, ng/mL | 0.91 | 0.86–0.95 |
| 40 mg, fed | ||
| AUC0–t, ng · h/mL | 1.00 | 0.96–1.05 |
| AUC0–inf, ng · h/mL | 1.02 | 0.97–1.08 |
| Cmax, ng/mL | 1.01 | 0.94–1.07 |
Abbreviations: 6-OH-oxymorphone, 6-hydroxy-oxymorphone; 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; Oxy-CRF, crush-resistant oxymorphone extended release; Oxy-ER, oxymorphone extended release; CI, confidence interval.