Bioequivalence and Bioavailability Forum

Dear All

While going through the BE guidance of Fexofenadine Hydrochloride Orally Disintegrating Tablets, I came to know that only fasting study is required for ODT

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086183.pdf

But for Fexofenadine Hydrochloride suspension and IR formulation fasting and fed both studies are required.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm082258.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086185.pdf

Even in SBoA, it is clearly 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 empty stomach

What could be the rational behind doing only fasting biostudy for Fexofenadine Hydrochloride Orally Disintegrating Tablets?

Bhupesh