Food-effect studies

Quart BD, Chapman SK, Peterkin J, Webber S, Oliver S. Phase 1 safety, tolerance, pharmacokinetics and food effect studies of AG1343—a novel HIV protease inhibitor. Abst. LB3. In Proceedings of the 2nd National Conference on Human Retroviruses and Related Infections. 1995 163. 

However, the food-effect study on Sporaffooral solution in healthy subjects observed that oral bioavailability of itraconazole actually decreased by 31 % under fed condition (Van de Velde et al., 1996). Thus, in its product labeling, it is indicated that SporShoral solution should be taken without a meal to ensure maximal absorption. Further, Spof Dcad solution and capsules should not be used interchangeably. 

A single-dose, food-effect study on the highest strength... 

Food-Effect Studies. Coadministration of food with oral drug products may influence drug BA and/or BE. Food-effect BA studies focus on the effects of food on the release of the drug substance from the drug product as well as the absorption of the drug substance. BE studies with food focus on demonstrating comparable BA between test and reference products when coadministered with meals. Usually, a single-dose, two-period, two-treatment, two-sequence crossover study is recommended for both food-effect BA and BE studies. 

HUMAN FOOD-EFFECT STUDIES AND AVAILABLE PHARMACOKINETIC METHODOLOGIES... 

In general, however, it is recommended to perform specific well-designed food-effect studies with adequate power for large differences to capture meaningful deviations in exposure. 

Karim, A. Importance of food effect studies early in drug development. In Bioavailabilit-y, Bioequivalence, and Pharmacokinetic Studies, Midha, K.K., Nagai, T., Eds. ... 

Food-effect studies are necessary for all multisource modified-release formulations to ensure the absence of dose dumping . The latter signals a formulation failure such that the dose is released all at once rather than over an extended period of time. This results in a premature and abrupt rise in the plasma concentration time profile. A high-fat meal often provides a maximal challenge to the robustness of release from the formulation with respect to prandial state. The composition of the meal should also take local diet and custom into consideration (see also section 6.2.4). 

Table 6.5 AUC and Cmax estimates from a 2-period crossover food-effect study.

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