Bioequivalence and Bioavailability Forum

Dear pash413

If the reference medicinal product can be taken with or without water, bioequivalence should be demonstrated without water as this condition best resembles the intended use of the formulation. This is especially important if the substance may be dissolved and partly absorbed in the oral cavity. If bioequivalence is demonstrated when taken without water, bioequivalence when taken with water can be assumed. If bioequivalence between chewable test formulation taken without water and reference formulation with water is demonstrated in a 2-period study, bioequivalence of chewable taken with water can be assumed.

In studies evaluating chewable tablets without water, it is recommended to wet the mouth by swallowing 20 ml of water directly before applying the chewable tablet on the tongue. It is recommended not to allow fluid intake earlier than 1 hour after administration.

I hope this helps
Kind regards
Dr_Dan