Healthy subjects
Conditions
Interventions
Alcohol clamping method
Alcohol clamping method Wash out Controlled Trial
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age: 20 years or older, less than 30 years 2.Gender: Healthy Japanese men and women without disease 3.Right-handed person 4.Nonsmoker 5.Person who drink alcohol more frequently than once or twice a month. 6.Individuals with ALDH2 alcohol-susceptibility genes *1/*2
Exclusion criteria
Exclusion criteria: 1.Patients with serious or past medical conditions of the heart, liver or kidney 2.Persons currently receiving continuous treatment with drugs 3.Persons with a history of drug or food allergy 4.Patients who are or have a history of treatment for drug dependence or abuse 5.Persons whose working hours are irregular, such as those who have worked at night 6.Subjects who are currently participating in another clinical study or have participated in another clinical study within the previous 3 months 7.Persons using cardiac pacemakers 8.Persons using vascular clips 9.Those using nerve electrical stimulators 10.Persons using implantable pumps 11.Persons in whom a piece of metal is in the body for some reason (including accidents and injuries) 12.Persons with tattoos (including one-point tattoos) 13.Persons with internal metal plates or screws for prostheses such as fractures 14.Other than the above, the investigator considered inappropriate for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI-measured data (T1, DTI, 1H-MRS, resting fMRI) VAS score for subjective symptoms of drunkenness | — |
Secondary
| Measure | Time frame |
|---|---|
| Ethanol Acetaldehyde Acetic acid Lactic acid Pyruvic acid Hematocrit Plasma glucose Plasma vasopressin Plasma TGFBeta Plasma amino acid | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed