Table 5. Pharmacokinetic parameters (arithmetic mean) for bupropion and metabolites (Study 2543)
|
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 (%)b |
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) |
2.50
(1.07 – 3.50) [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) 364.4
(34) 457.8
(29) 50.5
(34) 65.7
(40) |
2.50
(1.07 – 5.00) [blacked out] (22) 12051.4
926) 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) |
amedium (range)
bcalculated by reviewer
85
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