Table 6. Bioequivalence Assessment for AK1BIOVAIL2571
|
|
Geometric
Mean |
Ratio
of |
90%
CI for the |
|
|
|
Reference |
Test |
Geometric Means |
Ratio
of Geometric Means |
|
Bupropion Cmax
(ng/ml) AUC0-t
(ng*h/ml) AUC0-∞
(ng*h/ml) |
139.5 1610.9 1663.6 |
145.1 1583.4 1636.1 |
1.04 0.98 0.98 |
(0.98,
1.10) (0.94,
1.03) (0.94,
1.03) |
|
Bupropion Erythroamino Alcohol Cmax
(ng/ml) AUC0-t
(ng*h/ml) AUC0-∞
(ng*h/ml) |
26.77 1360.3 1499.9 |
28.2 1405.1 1555.1 |
1.05 1.03 1.04 |
(0.99,
1.11) (0.97,
1.10) (0.97,
1.11) |
|
Bupropion Threoamino Alcohol Cmax
(ng/ml) AUC0-t
(ng*h/ml) AUC0-∞
(ng*h/ml) |
152.9 6724.6 8325.6 |
163.6 6905.2 8427.7 |
1.07 1.03 1.04 |
(1.00,
1.14) (0.97,
1.09) (0.95,
1.09) |
|
Hydroxybupropion Cmax
(ng/ml) AUC0-t
(ng*h/ml) AUC0-∞
(ng*h/ml) |
446.7 20679.9 21631.2 |
459.5 20674.3 21573.2 |
1.03 1.00 1.00 |
(0.98,
1.08) (0.94,
1.06) (0.94,
1.06) |
|
PAWC Cmax (µM) AUC0-t
(µM*h) AUC0-∞
(µM*h) |
152.9 6724.6 8325.6 |
163.6 6905.2 8437.8 |
1.06 1.00 1.00 |
(1.00,
1.12) (0.95,
1.06) (0.95,
1.06) |
Reanalysis
of the data by the reviewer was in agreement with that provided by the sponsor
regarding the bioequivalence between the test and reference treatments.
The
90% confidence intervals on the geometric means of the Cmax, AUC0-t,
AUC0-∞ ratios are within the bioequivalence interval of 0.80
to 1.25.
Safety
Approximately
17% of subjects in either the test or reference periods experienced a drug-related
adverse event. Headache was the most
common drug-related adverse event and occurred to a similar extent in both
treatments.
CONCLUSIONS:
This
study has demonstrated equivalence between bupropion extended release given as a
single 300 mg tablet and a single dose of bupropion extended release given as
2x150 mg tablets. Thus, dosage strength
equivalence has been demonstrated.
79
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