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This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects.
This will be a randomized, open-label, 3-way crossover design study to investigate the effect of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| under fasting condition group | Experimental | Subjects will receive a single dose of ASP1941 under fasting condition |
|
| before meal group | Experimental | Subjects will receive a single dose of ASP1941 before meal |
|
| after meal condition | Experimental | Subjects will receive a single dose of ASP1941 after meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1941 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax | Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax) | For 72 hours after each administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance | Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ) | For 72 hours after each administration |
| Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests |
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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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| For 72 hours after each administration |
| Changes in urinary glucose excretion | Before and for 72 hours after each administration |