Bioequivalence and Bioavailability Forum

Dear All,



We are planning to conduct bioequivalence study of Modafinil 100 mg tablets for Australia submission. Modafinil is a racemic compound and in SMPC it has been mentioned that “the enantiomers have different pharmacokinetics where the elimination t1/2 of the R-isomer is three times that of the S-isomer in adult humans”. However they are pharmacologically equipotent.

As per applicable guideline, whether we need to establish bioequivalence on each enantiomer or racemic will suffice the regulatory requirement.