Table 3.
Pharmacokinetic parameters of oxycodone after a single oral dose of test and reference tablet (10 mg) under fed conditions in healthy male Japanese subjects (study 2)
| Variables | Test (N = 24) | Reference (N = 23) |
|---|---|---|
| C max (ng/ml) | 17.0 (18.8) | 15.0 (17.2) |
| AUCt (ng·h/ml) | 156 (16.5) | 156 (19.8) |
| AUCinf (ng·h/ml) | 157 (16.7) | 158 (20.1) |
| t max (h) | 4.50 (2.00; 5.50) | 3.50 (2.00; 5.00) |
| t ½ (h) | 4.26 ± 0.574 | 5.45 ± 0.676 |
Values are geometric mean (%CV), except for t max, which is presented as median (minimum; maximum), and t ½, which is presented as arithmetic mean ± standard deviation
AUC inf AUC up to infinity, AUC t area under the plasma concentration–time curve to the last sampling time, C max maximum plasma concentration, %CV coefficient of variation, t max time to reach maximum concentration, t ½ terminal elimination half-life