Appendix 5.1.1 Tables of All
Studies
Phase 1 Studies: Dose Bioequivalence and
Availability Studies
Protocol |
Blind |
Design |
Length |
Dosing |
Setting |
Diagnosis |
Levels |
Bupropion
(po) |
N* |
201 |
Open |
Randomized Crossover |
Single Dose |
Fixed |
Inpatient |
Healthy Male Volunteers |
3 |
150 mg SR |
12 |
150 mg SR (alternate formulation) |
12 |
||||||||
2 x 75 mg IR |
12 |
||||||||
204 |
Open |
Randomized Crossover |
Single Dose |
Fixed |
Inpatient |
Healthy Male Volunteers |
3 |
2 x 50 mg SR |
24 |
100 mg SR |
24 |
||||||||
100 mg IR |
24 |
||||||||
202 |
Open |
Randomized Crossover |
Single Dose |
Fixed |
Inpatient |
Healthy Male Volunteers |
3 |
150 mg SR after fasting |
24 |
150 mg SR after breakfast |
24 |
||||||||
2 x 75 mg IR after fasting |
24 |
||||||||
206 |
Open |
Randomized Crossover |
4 weeks |
Fixed |
Outpatient |
Healthy Male Volunteers |
2 |
150 mg SR q12h |
36 |
100 mg IR tid |
36 |
||||||||
207 |
Open |
Randomized Crossover |
Single Dose |
Fixed |
Inpatient |
Healthy Male Volunteers |
3 |
6 x 50 mg SR |
36 |
3 x 100 mg SR |
36 |
||||||||
2 x 150 mg SR |
36 |
*
Number of patients randomly assigned to treatment.
Bupropion Sustained-Release Clinical Review 45
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