Japanese healthy adults
Conditions
Interventions
Furosemide 20mg p.o. Single dose
Spironolactone 50mg p.o. Sigle dose
Tolvaptan 7.5mg p.o. Single dose
Biofermin p.o.(as a placebo) Single dose
Sponsors
Showa University School of Medicine Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects are competent to consent, keep the rules of the study and are able to report self condition. 2) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
Exclusion criteria
Exclusion criteria: 1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements). 2) Any history for drug allergy 3) Subjects who are taking in too much alcohol 4) Subjects within three months after the participation to other clinical trials 5) Subjects who are inadequate for enrollment judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison the diuretic effects in study drugs evaluated by urine volume, urine specific gravity and excretion volume of electrolytes in urine | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment (biomarkers of renal injury, vital measurement, serum electrolytes, excretion and adverse event) | — |
Countries
Japan
Contacts
Public ContactNaoki Uchida MD, PhD
Showa University School of Medicine Department of Clinical Pharmacology
Outcome results
None listed