|
Table 5.1.2.3 Demographic Profile for
Phase 3 Seizure Incidence Study |
||
|
Parameter |
Bupropion (N-3100) |
|
|
Age
(Years) |
Mean |
42 |
|
Standard
Deviation |
12 |
|
|
Range |
18-86 |
|
|
Gender |
Male |
37.6% |
|
Female |
62.4% |
|
|
Race |
White |
89.5% |
|
Black |
7.0% |
|
|
Other |
3.5% |
|
5.1.3
Extent of Exposure (dose/duration)
Table
5.1.3.1 shows the numbers of patients in Phase I trials according to mean daily
bupropion sustained-release dose and duration of administration. A majority of patients (55.3%) were exposed
to 300 mg/day dosing. The mean daily
dose and duration of bupropion sustained-release treatment for patients in
Phase 2 and 3 trials is shown in Table 5.1.3.2. The majority of patients studied (53.9%) were treated with 300
mg/day. The three Phase 2-3 represent
439 patient-years of exposure to bupropion sustained-release.
|
Table 5.1.2.3 Number and Percentage of
All Volunteers Receiving Bupropion Sustained-Release According to Mean Daily
Dose and Duration in Phase 1 Clinical Pharmacology Studies |
|||||
|
Duration
(Days) |
100 mg |
150 mg |
300 mg |
Total |
Percentage |
|
1 |
2 |
0 |
1 |
3 |
2.3% |
|
2 |
21 |
36 |
1 |
58 |
43.9% |
|
3 |
0 |
0 |
37 |
37 |
28.0% |
|
14 |
0 |
0 |
34 |
34 |
25.8% |
|
Total |
23 |
36 |
73 |
132 |
|
|
Percentage |
17.4% |
27.3% |
55.3% |
|
100% |
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