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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tablet-1 | Experimental |
| |
| tablet-2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1941 | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of unchanged ASP1941 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 5 days after each administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu | Japan |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
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