Bioequivalence and Bioavailability Forum

Hi ElMaestro,

We are hoping to show that the nutritional supplement increases the absorption and thus bioavailability of the drug. Clinically this medication is known to have low bioavailability, often leading to low systemic exposure below the therapeutic target in patients and potentially reducing its efficacy. It has been shown that meals (particularly high fat meals) substantially increase the bioavailability, so we are hoping to see this effect with a nutritional supplement.

We are also interested in examining if the different doses of the supplement affect the bioavailability of the drug to a different extent, so that if increased bioavailability is observed, we will be able to make a recommendation of how much supplement is needed to optimise the systemic availability of the drug. Thus we are interested in comparing the AUC's between the reference (drug alone) and the drug + differing doses of the supplement (treatments B - D).

Michael