However, oral drug administration has certain limitations compared with intravenous (IV) administration that are mainly due to the influence of physiological factors in the gastrointestinal (GI) system, such as gastric acid secretions, pH, gastric emptying rate, secretion of bile acid and food consumption. Oral administration of drugs has several advantages over other administration routes, including lack of pain, ease of administration, portability and availability of convenient dosage forms (dissolving tablets, sustained-release (SR) tablets, and solution or suspension forms), which increases compliance in patients . The mechanism-based PK model of fenofibrate can quantify the effects of food on drug absorption by food type and calorie content. ConclusionsĪ mechanistic GI absorption model for quantitatively evaluating the effects of food on fenofibrate absorption was successfully developed, and acceptable parameters were obtained. The final model displayed good prediction power and precision. Increased calories in the duodenum increased the absorption rate constant of the drug in fed conditions (standard meal = 16.5%, high-fat meal = 21.8%) compared with fasted condition. The gastric emptying rate increased by 61.7% during the first 6.94 h after food consumption. Similarly, to explain changes in gastric emptying time for the drug due to food effects was evaluated. Both linear and nonlinear effects were evaluated to explain the impact of food intake on drug absorption. The model was developed by nonlinear mixed effect modeling method. MethodsĬlinical data from a fenofibrate PK study involving three different conditions (fasting, standard meals and high-fat meals) were used. The aim of this study was to develop a mechanistic GI absorption model for explaining the effect of food on fenofibrate pharmacokinetics (PK), focusing on the food type and calorie content. Consumption of food is one of the major factors affecting the GI system and consequently the absorption of drugs. Oral administration of drugs is convenient and shows good compliance but it can be affected by many factors in the gastrointestinal (GI) system.