Dehydration
Conditions
Interventions
OS-1 group (OS-1 is consumed first) Sequence: OS-1 - wash out - MW
MW group (MW is consumed first) Sequence: MW - wash out - OS-1
Sponsors
Otsuka pharmaceutical Factory, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)male, 20 years of age or older (on the day of informed consent acquisition) 2)body weight between <=50kg and >70kg and body fat 25% or less (The percent of body fat measures it with a commercial body fat calculator) 3) The person that abnormality to become the problem for a study entry by screening examination carried out in an enforcement medical institution is not recognized
Exclusion criteria
Exclusion criteria: 1) The person who performed 400mL of whole blood drawing within 12 weeks before examination food intake of stage I The person who performed 200mL of whole blood drawing within four weeks before examination food intake of stage I The person who performed apheresis (plasma ingredient or platelet ingredient) within two weeks before examination food intake of stage I 2) Person who participated in medication clinical trial within 12 weeks before examination food intake of stage1 3) the person who sweated a large amount by sauna bathing or an intense movement etc within three days before entering of the medical institution 4) Person who was judged unsuitable as subject of examination by examination doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative urine volume, blood osmolarity | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum electrolyte (Na, K, Cl),hemoglobin, hematocrit, serum total protein, serum albumin blood urea nitrogen, serum glucose, water and electrolyte balance (Na, K, Cl) ,FeNa, sweat electorolyte (Na, K, Cl) ,body weight change, body weight change rate | — |
Countries
Japan
Contacts
Public ContactKenichi Inada
Medical Co. LTA Kyushu Clinical Pharmacology Research Clinic Planning and Coordination Dept
Outcome results
None listed