Bioequivalence and Bioavailability Forum

Hi,

Is it possible to fail a BE study on applesauce give that the fasting BE (non-applesauce) study is perfectly bioequivalent. The drug has intrasubject CV in the 15-20% range, not HVD. The 90% CI has a upper limit of 120% (still less than 125). Fed study is BE was well.

I mean if everything goes well, no dropping of capsule content, subject swallowed all the apple sauce + drug content.

Just curious if the capsule shell itself would have an effect.

Thanks

John