in
the first treatment period and the first dose of the second period. The 300 mg dose of the extended release
product is the highest proposed dosage strength of this product.
Table 2. Treatment Sequence in AK1BIOVAIL2543
|
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 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 progestogen drug was not allowed within 1 year prior to investigational product administration.
The
morning doses of study drugs were administered with 240 ml of room temperature
water after an overnight fast of at least 10 hours. The other doses during the day were given with 240 ml of room
temperature water after a fast of at least 1 hour. 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. On days 1, 10, 11, and 12 of both treatment
periods, samples were collected at 0.0 hr (pre-dose). For Treatment A, blood samples collected on Day 13 at 0 hours
(pre-dose) and 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 14.0, 16.0,
20.0, and 24 hours after administration of study drug. For Treatment B, blood samples were collected
on Day 13 at 0 hr (Pre-dose), 1.0, 1.5, 2.0, 2,5, 3.0, 3.5, 4.0, 5.0, 6.0
(before study drug administration, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0,
11.0, 12.0 (before study drug administration), 12.5, 13.0, 13.5, 14.0, 1.50,
15.5, 16.0, 17.0, 18.0, 20.0, 22.0, and 24.0 hours after the 0.0 hour study
drug administration.
81
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