THE EFFECT OF FOOD ON THE ABSORPTION OF METHOTREXATE SODIUM TABLETS IN HEALTHY-VOLUNTEERS

Objective. To examine the effect of food on the absorption and bioavailability of low-dose orally administered methotrexate sodium tablets. Methods. In this randomized, 2-way crossover study, a 7.5-mg dose of methotrexate (three 2.5-mg tablets) was administered to 12 healthy male volunteers after an overnight fast or within 10 minutes of consuming a high fat-content breakfast. Serum methotrexate concentrations over the next 24 hours were used to determine the area under the concentration-time curve (AUC), the maximum concentration, the time to maximum concentration (t(max)), and the serum half-life for each phase. Results. Food delayed the t(max) by approximately 30 minutes, but the extent of absorption, as measured by the AUC, for both phases was similar. Conclusion. These results demonstrate that the bioavailability of low-dose orally administered methotrexate sodium tablets is not influenced by food.