Table 4.
Pharmacokinetic parameters for APAP following administration of ER OC/APAP (two tablets, 15 mg OC/650 mg APAP) under fed and fasted conditions
| Parameter | Treatment A high fat, mean (SD) (n=31) | Treatment B low fat, mean (SD) (n=31) | Treatment C fasted, mean (SD) (n=31) |
|---|---|---|---|
| AUC0–inf (μg · h/mL) | 31.5 (8.0)b | 30.6 (8.1) | 31.8 (7.9)b |
| AUC0–t (μg · h/mL) | 29.6 (7.8) | 29.3 (7.9) | 29.8 (7.6) |
| Cmax (μg/mL) | 3.8 (0.9)c | 3.9 (1.0)c | 5.2 (1.7) |
| tmax (hours)a | 2.00 (0.50–5.00)c | 2.00 (0.50–5.00)c | 0.53 (0.23–5.00) |
| tlag (hours)a | 0.00 (0.00–1.00)c | 0.25 (0.00–0.50)c | 0.00 (0.00–0.25) |
| CL/F (L/hour) | 22.1 (5.2) | 22.5 (5.4) | 21.7 (5.3) |
| Vd/F (L) | 154.3 (44.7) | 159.4 (53.1) | 192.3 (71.3) |
| Kel (1/hours) | 0.16 (0.04)b | 0.16 (0.04) | 0.11 (0.04)b |
| t1/2 (hours) | 4.7 (1.1)b,c | 4.7 (1.6)c | 6.6 (2.0)b |
Notes:
Median (minimum to maximum)
n=29
reached statistical significance versus the fasted condition.
Abbreviations: APAP, acetaminophen; AUC0–inf, area under the plasma drug concentration-time curve from time 0 to infinity; AUC0–t, area under the plasma drug concentration-time curve from time 0 to the last quantifiable data point; CL, clearance; Cmax, maximum observed plasma concentration; ER, extended release; F, oral bioavailability; Kel, apparent first-order terminal elimination rate constant; OC, oxycodone; t1/2, apparent plasma terminal elimination half-life; SD, standard deviation; tlag, time prior to the first measurable concentration; tmax, time to Cmax; Vd, volume of distribution.