Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SK Chemicals Co., Ltd.
With
Toray Industries, Inc
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
Patients aged 20 years or older
Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 \~ 130 %
Patients who can understand and follow instructions and participate in the study during the entire study period
Patients who signed the informed consent form before participating in the study
You may not be if
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
1. Azole antifungal agents
1. Ketoconazole
2. Fluconazole
3. Itraconazole
4. Clotrimazole
2. Macrolide antibiotics
1. Erythromycin
2. Midecamycin
3. Josamycin
4. Roxithromycin
5. Clarithromycin
6. Triacetyloleandomycin
3. Ritonavir
4. Cyclosporine
5. Nifedipine
6. Cimetidine
7. Amiodarone
Patients who had the following drinks and foods within 2 weeks before Day 1
1. Foods and drinks containing grape fruit juice
2. Food and drinks containing St. John's wort
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
