Healthy Clinical Trial
Official title:
ASP1941 Pharmacokinetic Study - Verification of Bioequivalence Between ASP1941 New Tablets and ASP1941 Conventional Tablets -
To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.
This study is a open-label randomized two-way crossover study. A single dose of two types of
ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group,
32 subjects in total).
In case the bioequivalence of the 2 formulations cannot be proved in this study due to
insufficient number of subjects, an add-on subject study will be conducted in this clinical
trial as needed. Same design and methodology are to be applied to this study and the add-on
subject study. The add-on subject study may not be conducted.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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