NIPH Clinical Trials Search

Single-dose alcoholic beverage administration test for estimating blood, urine, and breath alcohol concentration

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	01/02/2025
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Single dose of alcoholic beverages

Outcome(s)

Primary Outcome

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 Outcome

- 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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	-Japanese healthy adults between the age of 20 to under 65 years -Those who the BMI between 18.5 to under 30.0
Exclude 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