Bioequivalence and Bioavailability Forum

Dear Members,

I have one question related to designing of food effect & bio-availability study.

As such there are three formulations to be tested. 1. Test product A 2. Test product B & 3. reference R.

The test products are from different batches. Study design what we have mentioned in the protocol is "An open label, balanced, randomized, five-treatment, five-sequence, five-period, single dose, crossover bioavailability & food effect study under fasting and fed condition in healthy adult subjects."

Both test products will be administered under fasting & fed conditions in different periods of the study. Hence when test product (A) to be administered under fasting condition it is coded as Test A1 & when administered under fed condition it will be coded as Test A2. Similarly coding is done for Test product B 1 & B2 when administered under fasting & fed condition respectively.

For one objective of the study viz. Assessment of food effect the comparison of interest is A2 vs. A1 and B2 vs. B1. While for the other objective of the study viz. Bioavailability Assessment the comparison of interest is A1 vs B1 vs R.

What should i mention in the study design. "Five treatment" (Considering the different condition as different treatment) or "Three treatment" (Considering the number of formulations to be tested).

Your views are highly appreciated.

Best regards.