|
NDA
20-358 |
7 |
2)
Plasma
levels of parent (and metabolite on day 10) were several fold higher in F than
in M.
3)
AUCs
of parent compound were several-fold greater on day 82 than on day 10 in
males. (A smaller increase was seen in
F at the higher doses). There was no
clear difference in AUC of the metabolite between days 10 and 82.
4)
On
day 10, levels of parent and metabolite were generally similar to each other
(except for greater levels of parent in LD and MD F). On day 82, levels of parent were generally several fold greater
than those of the metabolites at all doses in both sexes.
5)
On
day 10 in both sexes and on day 82 in M, levels of parent and metabolite at HD
were equal to or somewhat greater than those at HD*; the reverse was true in F
on day 82. (i.e. levels somewhat
greater in HD*).
It should be noted that the above conclusions are far from definitive in view of the small N and large inter-animal variation noted.
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