| |
Study 1 |
Study 2 |
| Parametera |
OC/APAP ER
(1 Tablet; 7.5/325 mg)
(n=33) |
OC/APAP ER
(2 Tablets; 15/650 mg)
(n=33) |
IR OC/APAP
(1 Tablet Twice; 15/650 mg)
(n=33) |
IR OC/APAP
(2 Tablets Twice; 30/1300 mg)
(n=27) |
OC/APAP ER
(2 Tablets; 15/650 mg)
(n=29) |
IR Oxycodone
(1 Tablet Twice; 30 mg OC)
(n=29) |
IR OC/APAP
(1 Tablet Twice; 15/650 mg)
(n=29) |
| AUC0-inf (ng•h/mL) |
89.9 (24.7)b |
187.7 (47.6) |
193.1 (53.2) |
403.0 (110.5) |
169.3 (37.0) |
336.3 (62.8) |
171.5 (34.1) |
| AUC0-t (ng•h/mL) |
87.4 (24.6) |
186.0 (47.6) |
191.2 (53.4) |
401.2 (110.6) |
167.9 (36.8) |
334.6 (62.5) |
169.9 (34.2) |
| Cmax (ng/mL) |
8.41 (2.1)c |
16.39 (4.3)c |
20.82 (6.0) |
41.24 (12.1) |
14.3 (2.9)c |
31.3 (8.2)c |
19.4 (4.6) |
| Tmax (h) |
4.0
(0.8-5.9)c |
3.0
(0.8-6.5)c |
7.8
(0.5-10.0) |
0.8
(0.5-12.0) |
4.0
(0.8-12.0)c |
8.0
(0.8-12.0) |
8.0
(0.5-12.0) |
| tlag (h) |
0.00
(0.00-0.50)c |
0.00
(0.00-0.52) |
0.00
(0.00-0.25) |
0.00
(0.00-0.25) |
0.00
(0.00-0.25) |
0.00
(0.00-0.27) |
0.00
(0.00-0.25) |
| t1/2 (h) |
4.5 (0.78)b,c |
4.9 (0.93)c |
4.1 (0.89) |
4.3 (1.02) |
4.5 (0.58)c,d |
3.9 (0.31) |
4.0 (0.48) |
| Kel (h-1) |
0.159 (0.031)b,c |
0.147 (0.027)c |
0.177 (0.035) |
0.169 (0.042) |
0.158 (0.022)c,d |
0.180 (0.014) |
0.176 (0.023) |
aAll data are mean (SD), except Tmax and tlag, which are median (minimum, maximum); bn=32; cReached statistical significance vs immediate-release oxycodone/acetaminophen (1 tablet, twice); dReached statistical significance vs immediate-release oxycodone.
AUC0-inf, area under the plasma concentration-time curve from time 0 to infinity; AUC0-t, area under the plasma concentration-time curve from time 0 to the last quantifiable
concentration; APAP, acetaminophen; Cmax, maximum observed plasma concentration; ER, extended-release; IR, immediate release; Kel, apparent terminal elimination rate
constant; OC, oxycodone; t½, terminal elimination half-life; tlag, lag time; Tmax, time to maximum observed plasma concentration |
