Healthy adults
Conditions
Interventions
Single dose of alcoholic beverages
Sponsors
Uemura Naoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Japanese healthy adults between the age of 20 to under 65 years -Those who the BMI between 18.5 to under 30.0
Exclusion criteria
Exclusion criteria: -Those with a history of hypersensitivity to alcohol (including those who cannot drink alcohol) -Those with illnesses that may affect the evaluation of the drug -Those whose total blood collection volume exceeds 1200 mL per year including the scheduled blood collection volume for this study -Pregnant and lactating women -Those with a history or suspected history of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of changes in blood sample concentrations of ethanol and alcohol metabolites, pharmacokinetics, and pharmacokinetics according to intake amount after drinking in healthy Japanese adults | — |
Secondary
| Measure | Time frame |
|---|---|
| - Excretion of alcohol metabolites into urine after drinking alcohol- Relationship between genetic polymorphisms of alcohol metabolism-related enzymes and blood ethanol and metabolite concentrations - Examination of drinking proof method using alcohol metabolites as biomarkers - Study on the usefulness of breath testing using multiple measurement points - Changes in depth vision before and after drinking alcohol - Relationship between drunkenness level and blood ethanol concentrations | — |
Contacts
Public ContactYuko Shimogori
Oita University Faculty of Medicine
Outcome results
None listed