Pharmacokinetic
parameters (arithmetic mean) for bupropion and metabolites (Study 2571)
|
|
Test (2x 150 mg tablets) (%
CV) n=35 |
Reference (300 mg tablet) (%
CV) n=35 |
|
Bupropion tmax(h)a Cmax
(ng/mL) AUC0-t
(ng*h/mL) AUC0-∞
(ng*h/mL) t1/2
(hr) λz
(hr –1) |
5.0
(3.5-8.00) [blacked out] (25) 1648.9
(29) 1702.7
(29) 22.7
(33) 0.0355
(49) |
5.00
(4.00-8.00) [blacked out] (32) 1676.6
928) 1728.3
(28) 21.8
(34) 0.0373
(49) |
|
Bupropion Erythroamino Alcohol tmax(h)a Cmax
(ng/mL) AUC0-t
(ng*h/mL) AUC0-∞
(ng*h/mL) t1/2
(hr) λz
(hr –1) |
16.00
(6.00-16.15) [blacked out] (23) 1508.8
(40) 1702.7
(46) 32.2
(27) 0.0232
(29) |
16.00 (5.50-24.00) [blacked out] (24) 1441.8
(34) 1613.6
(39) 32.1
(29) 0.0232
(26) |
|
Bupropion Threoamino Alcohol tmax(h)a Cmax
(ng/mL) AUC0-t
(ng*h/mL) AUC0-∞
(ng*h/mL) t1/2
(hr) λz
(hr –1) |
8.00
(5.00-16.00) [blacked out] (35) 7548.1
(48) 9428.7
(53) 50.5
(33) 0.0150
(31) |
8.00
(5.00-16.00) [blacked out] (36) 7262.9
(42) 9091.3
(43) 51.5
(33) 0.0149
(33) |
|
Hydroxybupropion tmax(h)a Cmax
(ng/mL) AUC0-t
(ng*h/mL) AUC0-∞
(ng*h/mL) t1/2
(hr) λz
(hr –1) |
10.00
(5.00-24.17) [blacked out] (37) 22506.3
(42) 23634.2
(44) 24.0
(20) 0.0301
(23) |
12.00
(6.00-24.00) [blacked out] (36) 22380.3
(39) 23498.8
(41) 24.1
(19) 0.0298
(19) |
|
PAWC tmax(h)a Cmax
(µM) AUC0-t
(µM*h) AUC0-∞
(µM*h) t1/2 (hr) λz
(hr –1) |
5.50 (4.00-12.00) [blacked out] (24) 67.3
(35) 71.0
(37) 25.9
(20) 0.0281
(24) |
5.50 (4.50-24.00) [blacked out] (27) 66.8
(33) 70.4
(34) 25.9
(19) 0.0278
(21) |
amedium (range)
The
90% confidence intervals on the geometric means of the Cmax, AUC0-t,
and AUC0-∞ ratios are within the bioequivalence interval of
0.80 to 1.25. Therefore, the two dosage
strengths are considered bioequivalent.
27
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