| |
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 tramadol/APAP
(1 Tablet Twice;
75/650 mg)
(n=29) |
IR OC/APAP
(1 Tablet Twice; 15/650 mg)
(n=29) |
| AUC0-inf (ng•h/mL) |
16995 (5073) |
34836 (11067)b |
34236 (10126)b |
71949 (24234)c |
30759 (7000) |
30989 (6759) |
30368 (7291) |
| AUC0-t (ng•h/mL) |
15871 (4841) |
32665 (10894) |
33040 (9589) |
69837 (22945) |
29065 (6851) |
29935 (6578) |
29193 (6892) |
| Cmax (ng/mL) |
2632 (918) |
5230 (2086) |
4878 (1545) |
10741 (4123) |
4654 (1360) |
4256 (1004) |
4387 (1326) |
| Tmax (h) |
0.8
(0.3-2.0) |
0.8
(0.3-4.0) |
0.5
(0.3-9.0) |
0.5
(0.3-12.0) |
0.8
(0.5, 2.0)e |
2.0
(0.5, 9.0)d |
0.8
(0.3, 12.0)e |
| tlag (h) |
0.0
(0.0-0.5)d |
0.0
(0.0-0.3) |
0.0
(0.0-0.0) |
0.0
(0.0-0.0)d |
0.0
(0.0, 0.3) |
0.0
(0.0, 0.5) |
0.0
(0.00, 0.3) |
| t1/2 (h) |
5.3 (1.53)d |
6.9 (2.15)b,d |
4.4 (1.16)b |
5.8 (1.47)c,d |
5.8 (2.07)d,e |
4.1 (1.08) |
4.4 (1.24) |
| Kel (h-1) |
0.142 (0.048)d |
0.110 (0.034)b,d |
0.167 (0.041)b |
0.129 (0.037)c,d |
0.133 (0.038)d,e |
0.178 (0.040) |
0.168 (0.044) |
aAll data are mean (SD), except Tmax and tlag, which are median (minimum, maximum); bn=32; cn=25; dReached statistical significance vs immediate-release oxycodone/acetaminophen (1 tablet, twice); eReached statistical significance vs immediate-release tramadol/acetaminophen.
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 |
