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The purpose of this study is to assess the bioequivalence between ASP1585 granules and ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules under open-label conditions in non-elderly healthy male subjects. In addition, the safety of these products is assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1585 granules preceding group | Experimental |
| |
| ASP1585 capsules preceding group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP1585 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average daily amount of urine phosphorus change from baseline | Average daily amount of urine phosphorus on Day 5 to Day 8 was compared with that on Day -4 to Day 1 (baseline) | Day 5 to Day 8 after start of each dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile assessed by the incidence of adverse events, vital signs, clinical laboratory tests, and 12-lead ECG | ECG: Electrocardiogram | Up to Day 17 on Period 2 |
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Inclusion Criteria:
Exclusion Criteria:
Received or scheduled to receive any investigational drugs in other clinical trials, post-marketing studies, or clinical studies within 120 days before the screening or during the period from the screening to 1st hospitalization.
Donated or scheduled to donate 400 mL of whole blood within 90 days before the screening or during the period from the screening to 1st hospitalization, 200 mL of whole blood within 30 days before the screening or during the period from the screening to 1st hospitalization, or blood components within 14 days before the screening or during the period from the screening to 1st hospitalization.
Any deviation of the laboratory tests at screening or 1st hospitalization.
A deviation from the normal range of blood pressure, pulse rate, or body temperature at screening or 1st hospitalization
History of drug allergies
Upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before 1st hospitalization
Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury, and hepatic impairment)
Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)
Concurrent or previous GI disease (e.g., ileus paralytic, gastric atony, intestinal atony, colitis ulcerative, peptic ulcer and gastroesophageal reflux esophagitis; except for a history of appendicitis).
Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
Previous use of bixalomer
Excessive smoking or drinking habit
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagoshima | Japan |
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| ID | Term |
|---|---|
| C000589735 | bixalomer |
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