Bioequivalence and Bioavailability Forum

Hi,

Greetings to all !!!!

We have conducted a study wherein two different innovator treatments, each comprising single drug are given in the following manner: 1) Reference A alone 2) Reference B alone and 3) Reference A+B. This was a six sequence, 3 period crossover study. The objective was to evaluate occurrence of drug interaction between the study treatments. The data obtained after administration of Reference A+Reference B (combination) is treated as test and each drug (Reference A or Reference B) compared separately with the corresponding reference treatment when given alone. Thus we had Reference A (in combination) Vs Reference A (alone) and Reference B (in combination) Vs Reference B(alone) for the comparison. As each drug (either Reference A or Reference B) is given only in two of 3 study periods, each comparison is to be done as if there are 2 different periods, 2 treatments crossover studies. This will result in degrees of freedom of 1 and 2 different sets of intra-subject variation.

Is this a correct way or is there any alternative way wherein the degrees of freedom could be 2 and only one set of intra-subject variation is present?

Thanks in advance.