Steady State pharmacokinetic parameters (arithmetic mean) for bupropion and metabolites
|
Test (Bupropion XL)
(% CV) n=30 |
Reference (Wellbutrin)
(% CV) n=30 |
Bupropion
Tmax
(h)a Cmax
(ng/mL) AUC0-24
(ng*h/mL) Cmin
(ng/ml) Cav
(ng/ml) Degree
of Fluctuation (%) Swing
(%) |
5.00
(3.00-7.00) [blacked out] (28) 1612.0 (30) 27.6
(39) 67.2
(30) 212.6
(19) 554.6
(35) |
1.50 (1.00-3.00) [blacked out] (32) 1792.0 (27) 34.1
(37) 74.7
(27) 190.0
(21) 439.6
(32) |
Bupropion Erythroamino Alcohol
Tmax
(h)a Cmax
(ng/mL) AUC0-24
(ng*h/mL) Cmin
(ng/ml) Cav
(ng/ml) Degree
of Fluctuation (%) Swing (%)b |
8.00 (5.00-14.00) [blacked out] (27) 2145.7 (29) 76.5
(34) 89.4
(29) 38.1
(40) 46.0
(35) |
2.5 (1.07-3.5)
[blacked out] (22) 2353.7 (27) 85.6
(31) 98.1
(27) 38.9
(87) 46.2
(94.7) |
Bupropion Threoamino Alcohol
Tmax
(h)a Cmax
(ng/mL) AUC0-24
(ng*h/mL) Cmin
(ng/ml) Cav
(ng/ml) Degree
of Fluctuation (%) Swing (%)b |
8.00
(5.00-14.00) [blacked out] (27) 10987.9
(29) 364.6
(34) 457.8
(29) 50.5
(34) 65.7
(40) |
2.50 (1.07-5.00) [blacked out] (22) 12051.4
(26) 415.7
(29) 502.1
(26) 45.2
(48) 56.3
(52) |
Hydroxybupropion
Tmax
(h)a Cmax
(ng/mL) AUC0-24
(ng*h/mL) Cmin
(ng/ml) Cav
(ng/ml) Degree
of Fluctuation (%) Swing (%)b |
7.00 (4.00-14.00) [blacked out] (35) 20824.8
(36) 722.2
(39) 867.7
(36) 44.3
(37) 54.6
(41) |
2.50 (1.00-4.00) [blacked out] (29) 22456.1
(31) 800.9
(33) 935.7
(31) 40.8
(77) 49.2
(83) |
PAWC
Tmax
(h)a Cmax
(µM) AUC0-24
(µM*h) Cmin
(µM) Cav
(µM) Degree
of Fluctuation (%) Swing (%)b |
6.00 (4.00-14.00) [blacked out] (25) 66.5
(27) 2.2
(32) 2.8
(27) 57.7
(21) 75.2
(35) |
2.00 (1.00-3.00) [blacked out] (22) 72.1
(23) 2.4
(26) 3.0
(23) 50.1
(36) 62.9
(39) |
bcalculated by reviewer
No evidence of dose-dumping was observed after administration of WELLBUTRIN XL.
The
90% confidence intervals on the geometric means of the Cmax, Cmin,
and AUC0-24 ratios are within the bioequivalence interval of 0.8 to
1.25 for bupropion and its metabolites, and the PAWC, with the exception of
bupropion Cmin. Cmin
was approximately 19% lower for WELLBUTRIN XL than the Reference
formulation and the ratio of geometric means was 0.8
19
Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page