Table 2.
Parameter | ORF-C vs ORF-F | ORF-F vs OC-F | ORF-C vs OC-F | |
---|---|---|---|---|
C max (ng/mL) | Mean ratio of PK metric (90 % CI) | 86.3 (76.91, 96.78) | 77.6 (69.27, 87.02) | 67.0 (59.76, 75.07) |
AUC∞ (ng·h/mL) | Mean ratio of PK metric (90 % CI) | 103.0 (91.64, 116.10) | 97.4 (86.56, 109.50) | 100.0 (89.29, 112.94) |
Treatment groups were ORF-C 10 mg (n = 29), ORF-F (n = 29), and OC-F 10 mg (n = 30)
AUC ∞ area under the plasma concentration-time curve extrapolated to infinity; CI confidence interval, C max maximum observed plasma concentration, OC-F finely crushed original formulation of oxycodone HCl controlled release, ORF-C coarsely crushed reformulated oxycodone HCl controlled release, ORF-F finely crushed reformulated oxycodone HCl controlled release, PK pharmacokinetic