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 (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.


CONCLUSIONS
These results demonstrate that the bioavailability of low-dose orally administered methotrexate sodium tablets is not influenced by food.
Kozloski
G D
GD
Medical Development Section, Lederle Laboratories, Pearl River, New York 10965.
De Vito
J M
JM
Kisicki
J C
JC
Johnson
J B
JB
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D004435:Eating / Q000502:physiology*; D005215:Fasting / Q000502:physiology; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood*; D008875:Middle Aged; D012016:Reference Values
D008727:Methotrexate