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| Name | Class |
|---|---|
| Toray Industries, Inc | INDUSTRY |
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The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRK-820 5 μg | Active Comparator | Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route |
|
| TRK-820 2.5μg | Active Comparator | Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nalfurafine hydrochloride | Drug |
|
Inclusion Criteria:
Exclusion Criteria:
Patients who have confirmed malignant tumor
Patients with cognitive impairment including depression, schizophrenia and dementia
Patients with hepatic cirrhosis as a complication
Patients with drug allergy to opioids
Patients with drug dependency or allergic disease (including skin response to UV radiation)
Patients who participated in other study and received the investigational drug within 1 month before the signing day
Patients who participated in other TRK-820 study within 4 weeks before the signing day
Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception
Patients who received any of the following drugs within 2 weeks before Day 1
Azole antifungal agents
Macrolide antibiotics
Ritonavir
Cyclosporine
Nifedipine
Cimetidine
Amiodarone
Patients who had the following drinks and foods within 2 weeks before Day 1
Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
Patients who smoked and drank from three months before the signing day
Patients who are ineligible for the clinical study for other reasons at the investigator's discretion
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| Name | Affiliation | Role |
|---|---|---|
| Wooseong Huh, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C111212 | TRK 820 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |