Bioequivalence and Bioavailability Forum

Dear all,

I was asked asked to design a pilot study to assess the CV_intra of an innovator’s product only (the generic is not ready, actually it’s some kind of feasibility issue).
Problems arise from the ‘pseudo randomisation’ – there’s only one product and sequences in a conventional 2×2 cross-over will be fixed a priori like this:
 S/P |  I  II
-----+-------
  1  |  R1 R2
  2  |  R2 R1
Of course the assignment to ‘R₁’ is ‘R₂’ is arbitrary; any other then the chosen one in the protocol will result in another PE and CV_intra…
Any ideas/suggestions?