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DailyMed – METAXALONE tablet


Food Effects

A randomized, two-way, crossover study was conducted in 42 healthy volunteers (31 males, 11 females) administered one 400 mg metaxalone tablet under fasted conditions and following a standard high-fat breakfast. Subjects ranged in age from 18 to 48 years (mean age = 23.5 ± 5.7 years). Compared to fasted conditions, the presence of a high fat meal at the time of drug administration increased C

max by 177.5% and increased AUC (AUC

0-t, AUC

) by 123.5% and 115.4%, respectively. Time-to-peak concentration (T

max) was also delayed (4.3 h

versus 3.3 h) and terminal half-life was decreased (2.4 h

versus 9.0 h) under fed conditions compared to fasted.

In a second food effect study of similar design, two 400 mg metaxalone tablets (800 mg) were administered to healthy volunteers (N=59, 37 males, 22 females), ranging in age from 18 to 50 years (mean age = 25.6± 8.7 years). Compared to fasted conditions, the presence of a high fat meal at the time of drug administration increased C

max by 193.6% and increased AUC (AUC

0-t, AUC

) by 146.4% and 142.2%, respectively. Time-to-peak concentration (T

max) was also delayed (4.9 h

versus 3.0 h) and terminal half-life was decreased (4.2 h

versus 8.0 h) under fed conditions compared to fasted conditions. Similar food effect results were observed in the above study when one metaxalone 800 mg tablet was administered in place of two metaxalone 400 mg tablets. The increase in metaxalone exposure coinciding with a reduction in half-life may be attributed to more complete absorption of metaxalone in the presence of a high fat meal (Figure 1).



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