Bioequivalence and Bioavailability Forum

Dear All!

May I pick your gut-feeling and/or experience on the following issue?

Due to a protocol violation in the second period of a two period cross-over BE study, the results of the second period cannot be used and this study period needs te be repeated. The violation did not present any safety hazard. The original second period is ongoing and has a long sampling interval post-dose.

Imagine that it is possible to do the paperwork in terms of amending the protocol to allow the second period to be repeated, make a new ICF, getting approval from the IRB, obtaining new study medication at the site on time, do you think the FDA will accept the outcome of the study in which the two arms are now the original first period and the repeated second period .

Or, imagine that it is not possible to do the paperwork on time, would it be acceptable to try to recruit the same subjects for participation in just one arm (repeat second period) and compare these results with the original first period. I know it is pretty optimistic to think that you can re-enter enough subjects for a second round..

Any thoughts or suggestions are very welcome, thanks in advance.

Frieda