Parameter, Units Adjusted Geometric Means Ratio (%) ALO-02/IRO 90% CI for Ratio (%)
ALO-02 40 mg IRO 20 mg
AUCinf(dn), ng∙h/mL/mg 12.75 11.90 107.2 (96.7, 118.8)
AUClast(dn), ng∙h/mL/mg 12.45 11.74 106.1 (95.35, 118.0)
Cmax(dn), ng/mL/mg 0.67 2.03 33.0 (28.80, 37.9)
ALO-02: extended-release oxycodone hydrochloride with sequestered naltrexone hydrochloride; AUCinf: area under the curve from time zero extrapolated to infinity; AUClast: area under the curve from time zero to the time of the last quantifiable concentration; CI: confidence interval; Cmax: maximum plasma concentration; dn: dose-normalized to 1 mg; IRO: immediate-release oxycodone.
Table 2: Statistical summary of treatment comparisons for dose-normalized plasma oxycodone pharmacokinetic parameters following single oral doses of ALO-02 40 mg capsules and IRO 20 mg tablets.