The
test meal consisted of the following: one fried egg, one slice of Canadian
bacon, one buttered English muffin, one serving of hash brown potatoes, one
slice of American cheese, eight ounces of whole milk, and six ounces of orange
juice. This meal (790 calories) derived
17% of calories from protein, 34% of calories from carbohydrate, and 49% of
calories from fat.
Other
meals and beverages were free of grapefruit products, xanthines, and caffeine,
and were identical during the study periods.
Table
2. Treatment Sequence in AK1BIOVAI2548
|
Sequence
Number |
Treatment
Period 1 |
Treatment
Period 2 |
|
1 |
A
(R) |
B
(T) |
|
2 |
B
(T) |
A
(R) |
Inclusion
criteria included healthy nonsmoking males or females, 18 years of age and
older. Exclusion criteria included use
of prescription medication (including monoamine oxidase inhibitors) within 14
days and over-the-counter medication within 7 days prior to the study. Oral contraceptives or contraceptive
implants were not allowed within 30 days and depot injection of a progestogen drug
was not allowed within 1 year prior to investigational product administration.
Subjects
were asked to abstain from alcohol, grapefruit juice, caffeine, and
xanthine-containing foods and fluids from 48 hours prior to the start of the
study period until the final blood draw.
Blood
samples were collected at fixed times and plasma stored at -70°C until
analyzed. Samples were collected at 0,
1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 13.0, 14.0, 15.0, 16.0, 17.0,
18.0, 20.0, 24.0, 36.0, 48.0, 72.0, 96.0, and 120 hours post-drug
administration.
ASSAY:
Table
3. Performance of Analytical Method for AK1BIOVAIL2548
|
Analyte |
Method |
Range (ng/ml) |
Linearity |
LOQ (ng/ml) |
QC (ng/ml) |
Inter- Day
CV (%) |
Inter-day
Accuracy (%) |
|
Bupropion |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
5.0 5.4* 3.3 6.5 |
[blacked out] |
|
Bupropion
Erythroamino alcohol |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
6.9 4.7* 3.2 3.6 |
[blacked out] |
|
Bupropion
Threoamino alcohol |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
6.2 3.9* 2.7 3.9 |
[blacked out] |
|
Hydroxybupropion |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
5.4 5.3* 3.8 6.6 |
[blacked out] |
*Excluding
samples that were out of acceptance range; calculated by reviewer.
68
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