Table 5.
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) |
5.00 (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 (28) 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 1411.8 (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)
Reanalysis
of this data by the reviewer was in agreement with the results presented by the
Sponsor, differing in only AUC0-∞, t1/2, and λz
by less than 5%.
78
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