urological diseases
Conditions
Interventions
1. Water loading test 2. Single dose of 60microgram Desmopressin
1. Water loading test 2. Single dose of 120microgram Desmopressin
1. Water loading test 2. Single dose of Placebo
Sponsors
Medical Co. LTA Sumida Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Age =>20 and Age <40 years. (at obtaining the informed consent) (2)Subject with weight =>50kg and <80kg (at screening test) (3) Subject with BMI =>18.5 and <25.0(at screening test) (4)The results of screening test are judged as eligible for this study subject by investigator (5)Subject is able to consent and give the written informed consent form.
Exclusion criteria
Exclusion criteria: (1)Subject with present illness. (2)Subject who has past medical history judged by investigator as an influence evaluate subject safety. (e.g. liver diseases, kidney diseases, cardiovascular diseases, hematologic diseases, endocrine system diseases, diseases of digestive system, diseases of respiratory system, infectious diseases, etc.) (3)Subject with diseases which possibly influence release and/or absorption of study drug ingredients. (4)Serum Na <137 mEq/L at screening test or a day before study drug administration. (5)Urination speed 0.12mL/kg/min from -30min to the time just before the study drug administration. (6)Subject had nausea and/or vomiting with water loading test at pre dosing. (7)History or presence of drug and/or alcohol dependence. (8) History or presence of drug allergy. (9) History or presence of food allergy. (10)Subject who take alcohol =>20g/day. (11)Dosing of any drug or supplements within 2 weeks prior to study drug administration. (12)Subject who smoked after screening test. (13)Subject who took food or beverages containing grapefruit (juice, flesh) within 3 days prior to study drug administration. (14)Use of other study drug for other clinical study within 12 weeks prior to study drug administration. (15)Subject who participated in other clinical study for medical devices within 12 weeks prior to study drug administration. (16) Subject who donated more than 400ml or 200ml of blood within 12 weeks or 4 weeks respectively, or component blood within 2 weeks prior to study drug administration, respectively. (17)Subject with positive test results of HIV antigen/antibody, HBs antigen, HCV antibody and/or syphilis. (18) Subject who are considered to be inadequate for this study by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC OSM AUC urine production, Time length which indicates urinary osmolality >200 mOsm/kg Time length which indicates urination speed <0.12 mL/kg/min (up to 12 hours post dose) | — |
Countries
Japan
Contacts
Public ContactIppei Ikushima
Medical Co. LTA Sumida Hospital Physician's Department
Outcome results
None listed