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In BE guidance of Fexofenadine Hydrochloride Orally Disintegrating Tablets
it is mentioned that only fasting study is required for
But for Fexofenadine Hydrochloride suspension and IR formulation fating and
fed both studies are required.
Even in SBoA, it is mentioned that food decreases the Cmax by 60% and AUC
by 40% for ODT, then why only fasting study is required for ODT and Fast
and Fed both for IR?
In BE guidance it is written that The whole tablet should be placed on the
tongue and allowed to disintegrate for 30 seconds. After 30 seconds, all
subjects should consume 240 mL of water.It means it will be a sort of IR
formulation only and In PIL its written ALLEGRA ODT should be taken on an
What could be the rational behind doing only fasting biostudy for
Fexofenadine Hydrochloride Orally Disintegrating Tablets?
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