Investigation on the procedure of water loading test in Japanese healthy volunteers
- Conditions
- urological diseases
- Registration Number
- JPRN-UMIN000019647
- Lead Sponsor
- SOUSEIKAI Sumida Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Not provided
(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, mental disorders, 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 400mlof blood within 12 weeks (male) /16 weeks (female), 200ml of blood within 4 weeks, or component blood within 2 weeks prior to study drug administration. For elderly subjects, besides the above criteria, investigators should take their health condition into consideration. (17)Subject with positive test results of HIV antigen/antibody, HBs antigen, HCV antibody and/or syphilis. (18)(c)Non-elderly female who are menstruating, pregnant or lactating on the day of the water loading test. (19) Subject who are considered to be inadequate for this study by investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Voided volume Urinary osmolality Urination speed
- Secondary Outcome Measures
Name Time Method