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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
32
Oral
Unnamed facility
Kyushu, Japan
Plasma concentration of unchanged ASP1941
Time frame: Before study drug administration on the administration day (Day 1), and 0.25,0.5,1,1.5,2,2.5,3,4,5,6,8,10,12,24,36,48,72 hours after administration
Safety assessed by vital signs (sitting blood pressure, sitting pulse rate, axillary body temperature), AEs (including subjective symptoms and objective findings), Laboratory tests (hematology, biochemistry, urinalysis) and 12-lead ECGs
Time frame: Up to 5 days after each administration
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