|
NDA
20-358 |
11 |
c)
Bodyweight
No drug effect
d)
Cytogenetic
data
No drug effects (Summary tables attached).
e)
PK
data
Plasma levels of bupropion and 3 metabolites were
measured in separate groups of animals receiving 300 mg/kg/day (degraded or undegraded)
for 5 days; samples taken 0.5 hr. after last dose; N = 5/sex/group. Results are shown in the attached
table. Levels of bupropion were
generally similar to those of metabolite 306U73. Levels of bupropion and metabolite 306U73 were greater in females
than in males. There was no clear
differences in levels between animals dosed with degraded vs undegraded drug,
but this cannot be concluded confidently in view of the small N and large
inter-animal variation.
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