Bioequivalence and Bioavailability Forum

Dear Dr_Dan,

❝ And now my question: Should the volunteer be advised to swallow the dispersed tablet and if yes when? How can I ensure that the drug reaches the GI tract in more or less the same time in all volunteers?

Very good question. Not sure I can answer without knowing the API, and not sure I can answer even if knowing the API. What did the originator do in their studies?

❝ If the originator SmPC tells me that the ODT can also be taken as an oral suspension I think then I should prefer this kind of application, right? In this context I would like to know the amount of water you need to prepare a suspension (240 ml?). The guideline does not mention suspensions....

Yes, an oral suspension would give you some advantages.
This sounds to me like the API is not subject to absorption from the oral cavity but please indicate if I am mistaking this; it could make a lot of difference. I imagine the fluid restraint for one hour was made with drugs in mind that are fully or partially absorbed through the oral mucosa. From that perspective I would expect the protocol to be OK even if you allow them to swallow a glass of water after adm. But get S.A. to be safe or wait until someone with better skills comes around to answer.