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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