Bioequivalence and Bioavailability Forum

❝ But unfortunately in Fed condition the AUC is meeting the BE limit same as fasting but the Cmax fails with the ratio of more than 120 % and CI limits are wider enough.

Dear Mr Sam,
The Prescribing information of Effient (Prasugrel) states that "In a study of healthy subjects given a single 15 mg dose, the AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and Tmax was increased from 0.5 to 1.5 hours". Hence, your fed study was not able to meet BE limits under Cmax only, not in AUC.
In my personal opinion, I would suggest to go for Pilot Fed study first and tries to match the test formulation with the reference formulation in Cmax and AUC. If the test formulation passes under fed conditions, the chances of this formulation becoming bioequivalent under fasting conditions are more.
I hope you would have taken different sampling time points for fed conditions since Tmax is 1.5 hours compared to 0.5 hrs under fasting conditions for active metabolite and also design the sampling points based on Tmax of Inactive metabolite R 95913 since Bioequivalence is based on 90% CI of inactive metabolite R 95913.
Standardize your high fat, high caloric fed breakfast menu as precise as possible so that no variability occurs among fed menu among different volunteers.