Oral bioavailability of XXXX is unaffected by food.

@entity1 @entity10 @entity14295
OBJECTIVE: To determine the effect of coadministration of food on the bioavailability of oral @entity14295 . DESIGN: A randomised, open-label, single dose crossover study in which healthy adults received a single, oral dose of @entity14295 7.5mg, 50% greater than the recommended dose of 5mg, under fed or fasted conditions and were then crossed over to receive the other treatment regimen. @entity1 : 18 healthy volunteers (11 @entity1 , 7 @entity1 ) aged from 18 to 43 (mean 29) years and weighing 54 to 104 (mean 76.4) kg were enrolled and completed this study. MAIN OUTCOME MEASURES: C(max), AUC(S) and AUC(infinity ). RESULTS: Maximum mean plasma concentration (C(max)) was 3.53 microg/L in fed compared with 3.30 microg/L in fasted @entity1 . Area under the plasma concentration-time curve from time 0 to time of final quantifiable sample (AUC(S)) mean values were 61.0 microg/L x h in fed and 61.9 microg/L x h in fasted @entity1 . Fed individuals had mean AUC extrapolated to infinity (AUC(infinity )) of 62.5 microg/L x h compared with 63.5 microg/L x h in fasted @entity1 . None of these differences between the fed and fasted state was statistically significant. The most frequently reported adverse event was @entity10 . There were no statistically significant changes in ECG parameters. CONCLUSION: The results of this study indicate that food has no effect on the oral bioavailability of a single oral dose of @entity14295 7.5mg.
