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This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.
This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders. |
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| Part 2 | Experimental | Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1941 | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change | For up to 72 hours after each administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests | For up to 10 days | |
| Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change | For 72 hours after ASP1941 administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantou | Japan |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
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| Mitiglinide calcium hydrate | Drug | oral |
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