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

JRCT ID: jRCT1070240083

Registered date:10/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 01/02/2025
• Target sample size: 30
• 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

Related Information

• Primary Sponsor: Uemura Naoto
• Source(s) of Monetary Support: Mitsui Sumitomo Insurance Welfare Foundation