Bioequivalence and Bioavailability Forum

Hi Angus,

How about just writing a new protocol, conduct a new study, semi-randomised uncontrolled and with one arm? Invite the same subjects to sign an ICF, use the rand. code from last time. Add arms as you please, to investigate aspects of the food effect.

Technically, I guess this makes certain formalities easier.

You'll end up in possession of data that you can analyse the same way in an exploratory fashion. From a GCP/Helsinki perspective this is "at least as OK" as adding an arm (anticipated benefit and risk same), and the paperwork and struggle with authorities/IRB's may be less. And you can avoid the issue of reconsenting, reopening a database, re-everything.