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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006525-11 | EudraCT Number |
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This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1941 | Drug | Oral | ||
| Placebo | Drug | Oral |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests | 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics assessed by the ASP1941 plasma concentration change | up to 96 hours after last dose | |
| Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine | up to 96 hours after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groningen | 9470 AE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21877761 | Derived | Veltkamp SA, Kadokura T, Krauwinkel WJ, Smulders RA. Effect of Ipragliflozin (ASP1941), a novel selective sodium-dependent glucose co-transporter 2 inhibitor, on urinary glucose excretion in healthy subjects. Clin Drug Investig. 2011 Dec 1;31(12):839-51. doi: 10.1007/BF03256922. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
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