Bioequivalence and Bioavailability Forum

Usually when studying a food effect the study is performed as a two way crossover study in the morning (fed v fasted). If the study drug formulation under examination is given in the evening then in the same way the food can be given in the evening and also crossed over with the fasted state in the evening.

I have an interest in study design precedence, where for an MR formulation:

(a) the MR formulation is given in the evening fasted and in the morning at~ 8 am there is a high fat breakfast.

Compared with

(b) the MR formulation is given in the evening fasted and in the morning at ~ 8 am there is no breakfast.

The idea is to investigate the influence of fed/fasted status in the morning on the bio availability of a MR formulation given the previous evening.

Drugs that can be administered in the evening that come to mind are verapamil and diltiazem, but of course there are many others.

I am looking for such studies and published results.


Angus