UNASSIGNED: Oral @entity1955 ( @entity2016 ) is the mainstay of @entity1375 treatment. Many factors may influence its absorption, including the timing of administration. Objective of the study is to demonstrate the therapeutic equivalence of administering liquid @entity2016 with breakfast or 10  min before breakfast. This was a pilot study conducted with a crossover design AB/BA where A stays for @entity2016 with breakfast and B for @entity2016 10  min before breakfast. A post hoc analysis was conducted to compare @entity2016 administered at breakfast or 10  min before breakfast with @entity2016 administered 30  min before breakfast. Sixty-one @entity1375 @entity1 were enrolled and assigned to one of the two treatment sequences. All @entity1 were evaluated for TSH levels at the end of each period. Fifty-nine @entity1 completed the study. The mean thyrotropin concentration was 1.52      0.73   U/ml when @entity2016 was administered with breakfast and 1.46      0.81   U/ml when it was taken 10  min before breakfast, without clinically and statistically significant differences (P  =  0.59), regardless of treatment sequence and period. The mean thyrotropin concentration was 1.54      0.9   U/ml when @entity2016 was administered at 0-10  min intervals before breakfast and 1.25      0.7   U/ml when it was taken 30  min before breakfast (ratio  =  1.23, within our definition of equivalence set at 0.8-1.25). There is therapeutic equivalence between liquid @entity2016 administration at breakfast or 10  min before breakfast. We can also hypothesize that there are no clinically relevant differences between liquid @entity2016 administration 30  min before breakfast or at shorter intervals.

Timing of breakfast does not influence therapeutic efficacy of liquid XXXX formulation.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1375 :: ('MESH:D007037', 'Disease') :: ['hypothyroidism', 'hypothyroid'] @entity1955 :: ('MESH:D013974', 'Chemical') :: ['levothyroxine'] @entity2016 :: ('CHEBI:18332', 'Chemical') :: ['L-T4']
@entity1955 :: (MESH:D013974,Chemical) :: ['levothyroxine']
