A randomized, crossover phase 1 study to assess the effects of formulation (capsule vs tablet) and meal consumption on the bioavailability of XXXX ( @entity36335 ).

@entity1 @entity390 @entity0 @entity5 @entity294 @entity391 @entity1295 @entity36335 @entity487 @entity489
PURPOSE: This 2-arm crossover study compared the relative bioavailability of two @entity36335 ( @entity36335 ) formulations [anhydrate clinical service form (CSF) capsule and monohydrate final market image (FMI) tablet; @entity487 ] and determined the effect of food on @entity36335 exposure ( @entity489 ). METHODS: @entity1 with advanced solid @entity5 , excluding @entity0 , were enrolled in 1 of the 2 arms of the study. @entity1 in @entity487 were randomized to a single 500-mg dose of CSF capsule or FMI tablet followed by 7  days of rest and 500  mg of the other formulation. @entity1 in @entity489 received 300  mg of FMI tablet daily and were randomized to follow 1 of 6 meal sequences, each with 3 prandial conditions: low fat (LF), high fat (HF), or no meal (NM). RESULTS: In @entity487 (n  =  21), 17 @entity1 were evaluable. FMI tablet compared with CSF capsule showed only slight reductions in the adjusted geometric means for area under the plasma concentration-time curve (AUClast; 3  %) and maximum plasma concentration (C max; 1  %). In @entity489 (n  =  42), 19 @entity1 were evaluable. HF meal versus NM showed a 9  % decrease in the adjusted geometric mean for AUClast and an 18  % decrease for C max. Comparison of LF meal versus NM showed a 1  % decrease for AUClast and a 10  % decrease for C max. Common adverse events suspected to be study drug related included @entity391 , @entity294 , @entity390 , and @entity1295 . CONCLUSIONS: @entity36335 FMI tablet had similar systemic exposure to the CSF capsule and was not affected by food.
