Bioequivalence and Bioavailability Forum

Dear All

We have a study that deals with One test drug and Two references. It is a pilot study comprising of 18 subjects. As far as I believe, we can go forward with a 6x3 design for the above study. But the sponsor has different thoughts. They want a 3x3 design with the same specifications? So is this feasible for a pilot study. Definitely a 3x3 design is good to ascertain results in a pivotal study but I do not think that same is the case in a pilot where you need a more balanced design. So what should be a valid design?

regards
Rajdeep