Studies in early clinical development

3. Food Effect Study

The objective of food effect studies is to evaluate the effect of food on the rate and extent of medicine absorption from a given formulation.

Food effect studies are typically run as single dose, crossover studies which compare two conditions: fed with a high-fat high-calorie meal versus fasted volunteers in a two-sequence study in healthy participants (n ≥12) using the highest strength of the medicine.

Researchers conduct a pharmacokinetic assessment similar to bioavailability and determine that there is no food effect if 90% of the fed/fasted Cmax and AUC ratios fall within the 80-125% range. The clinical significance of any observed food effect could be determined based on the medicine’s exposure-response profile.

The information gained from food effect studies:
  • Effect of food on the bioavailability (BA) of oral medicines
  • Labelling instructions [PL: package leaflet] on whether to administer medicine on empty stomach or without regard to meals