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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024071-98 | EudraCT Number |
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A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ipragliflozin | Experimental |
| |
| furosemide | Experimental |
| |
| ipragliflozin & furosemide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipragliflozin | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of urine sodium excretion, following multiple doses of ipragliflozin alone compared to furosemide + ipragliflozin in healthy subjects | 6 days | |
| Assessment of pharmacodynamic parameters (i.e. calcium, chloride, potassium, phosphate and magnesium in blood and urine) following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Furosemide | Drug | Oral |
|
| 9 days |
| Assessment of the pharmacokinetics of ipragliflozin when co-administered with furosemide compared to ipragliflozin alone | AUCtau (AUC during the time interval between consecutive dosing), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax) | 10 days |
| Assessment of the pharmacokinetics of furosemide when co-administered with ipragliflozin compared to furosemide alone | AUCtau (AUC during the time interval between consecutive dosing), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax) | 10 days |
| Assessment of the safety and tolerability of furosemide and ipragliflozin following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects | Assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia | 39 days |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |