The effect of food on the absorption of methotrexate sodium tablets in healthy volunteers

Abstract

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 (tmax), and the serum half-life for each phase. RESULTS: Food delayed the tmax 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.