|
NDA
20-358 |
9 |
No drug effects on the various parameters (see
attached table), including pre- and post-implantation loss, sex ratio, fetal
weight, and length, etc.
6)
Fetal
exam
No drug effects (see attached tables).
7)
PK
data
(This was actually a separate study using 16/sex/dose. On day 15 of gestation, plasma was sampled
pre-dosing and at 0.5, 1, and 4 hr. post-dosing (4/dose/time point) and assayed
for bupropion and 3 of its metabolites [306U73, 494U72, and 17U67]).
Results for bupropion and 306U73 are shown in the attached
table. (The other 2 metabolites were
not detected in any sample). Plasma
levels of parent compound were similar at all doses; level of the metabolite
were roughly dose-proportional. There
were no differences in PK parameters between HD and HD*. (Note the small N and large inter-animal
variation makes any conclusion problematic).
(Also note that in comparison to levels obtained in F in the 90 day
toxicity study, above, levels of bupropion were roughly similar, but levels of
306U73 were much higher in the present study).
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