Healthy, Urine Phosphorus Excretion
Conditions
Keywords
ASP1585, Bioequivalence, Pharmacodynamic, Phosphate binder, Bixalomer, urinary phosphorus excretion
Brief summary
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.
Interventions
DRUGASP1585
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight (at screening) ≥ 50.0 kg and \< 80.0 kg * Body mass index (BMI) (at screening) ≥ 17.6 kg/m2 and \< 26.4 kg/m2 * Healthy, as judged by the investigator/sub-investigator based on medical history and the results of physical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission to immediately before study medication in 1st period.
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 * Sitting blood pressure: Systolic blood pressure: ≥90 mmHg, ≤140 mmHg; Diastolic blood pressure: ≥40 mmHg, ≤90 mmHg * Sitting pulse rate; ≥40 bpm, ≤99 bpm * Axillary body temperature; ≥35.0°C, ≤37.0°C * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily amount of urine phosphorus change from baseline | Day 5 to Day 8 after start of each dosing | Average daily amount of urine phosphorus on Day 5 to Day 8 was compared with that on Day -4 to Day 1 (baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile assessed by the incidence of adverse events, vital signs, clinical laboratory tests, and 12-lead ECG | Up to Day 17 on Period 2 | ECG: Electrocardiogram |
Countries
Japan
Outcome results
None listed