None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Healthy males aged 20 or more and less than 50 years-old. 2)Subjects who can drink alcohol effortlessly. 3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: 1)Subjects whose systolic blood pressure is less than 90mmHg. 2)Subjects whose BMI is less than 20.0 and 23 or more. 3)Subjects who can't drink alcohol. 4)Subjects who are positive to alcohol patch test. 5)Subjects who drink alcohol a lot and smoke a lot. 6)Subjects who have an irregular sleep cycle, work shift or work on midnight shift 7)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. 8)Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks. 9)Subjects who are positive to hepatitis virus B, hepatitis virus C, HIV or human T-cell leukemia virus 10)Subjects who have allergic reaction to drug medicine and food. 11)Subject who are applicable to one of the below. a)Subject who are contracting heart, liver or kidney disease including the case of complicating disease. b)Subjects with a previous history of cardiovascular disease. c)Subjects who are contracting diabetes. 12)Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study. 13)Subjects whose blood was collected more than 400 mL within the last twelve weeks. 14)Subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 15)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy : Area under the curve of blood alcohol level. Safety : Adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy : Area under the curve of acetaldehyde level. Area under the curve of expired gas alcohol level. VAS. Safety : Adverse events | — |
Countries
Japan
Contacts
Suntory Global Innovation Center Ltd. Innovation Development Department