Table 2. Treatment Sequence in AK1BIOVAIL2571
|
Sequence
Number |
Treatment
Period 1 |
Treatment
Period 2 |
|
1 |
A
(T) |
B
(R) |
|
2 |
B
(R) |
A
(T) |
Inclusion
criteria included healthy nonsmoking males or females, 18 to 55 years of
age. 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 with 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, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, 96.0, and 120 hours post-drug administration.
ASSAY:
Table 3. Performance of Analytical Method for AK1BIOVAIL2571
|
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] |
7.1 5.0 4.0 3.3 |
[blacked out] |
|
Bupropion
Erythroamino Alcohol |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
6.4 5.0 3.2 2.8 |
[blacked out] |
|
Bupropion
Threoamino Alcohol |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
7.0 4.8 3.0 3.0 |
[blacked out] |
|
Hydroxybupropion |
LC/MS/MS |
[blacked out] |
[blacked out] |
[blacked out] |
[blacked out] |
5.3 4.2 3.4 3.8 |
[blacked out] |
Two
calibration curves and duplicate QC samples (at 4 concentration levels) were
analyzed with each batch of study samples.
At least 6 out of 8 QC samples were within [blacked out] of
their respective nominal value, except for 1 run for bupropion in which 5 out
of 8 samples were within [blacked out] of the nominal value. Study samples were stored at -70°C. Samples were analyzed within the period for
which the samples are stable at -70°C.
The performance of the assays for all analytes is considered acceptable.
75
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