None listed
Conditions
Interventions
Dietary Supplement : For test subjects who voluntarily sign and agree to participate in the human body application test, the selection/exclusion criteria are determined through visit 1 evaluation. Onl
Sponsors
Hyundai Bio Land Ansan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person aged 20 years or older and 40 years or less 2) Those with body mass index (BMI) of 18.5 kg/m2 or more and 25 kg/m2 or less 3) A person who has had a hangover after drinking alcohol 4) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) A person currently being treated for cardiovascular system (such as hypertension), immune system, respiratory system, endocrine system (such as diabetes), kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, and malignancy. 2) As of visit 1, those with peptic ulcer and reflux esophagitis, alcohol metabolism disorder, cholelithiasis, pancreatitis, gout, and liver disease (such as those with hepatitis B, C, and alcoholic liver disease). 3) A person who has a history of gastrointestinal diseases (such as Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of food for human application tests. 4) Person with alcohol-related disabilities as of visit 1. 5) A person who has drunk enough alcohol to interfere with the examination within one week on the basis of visit 1. 6) A person who usually consumes very little or abstains from alcohol within a month. 7) Drugs that are believed to affect alcohol metabolism (such as Disulfiram drugs), dietary supplements, and drugs at risk of gastrointestinal bleeding (Warfarin, clopidogrel, aspirin), A person who continues to take NSAIDs, other antipyretic and anti-inflammatory drugs, etc. 8) A person who has taken medicines, health functional foods, and hangover-relieving products related to the improvement of liver function within two weeks as of visit 1. 9) A person who has taken drug metabolism enzyme induction and inhibition drugs (Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole, etc.) within one month (30 days) as of visit 1. 10) A person who has administered antibiotics and intestinal medications within two weeks on the basis of visit 1. 11) A person who has administered or ingested probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visit 1. 12) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit. 13) A person whose creatinine is more than twice the normal upper limit of the implementation agency. 14) Those with a TSH of less than 0.1 µIU/mL or greater than 10 µIU/mL. 15) A person who is pregnant or has a plan to become pregnant during the lactating period or during the main human body application test. 16) A person who has participated in other interventional clinical trials (including human-applied trials) within one month of visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) after the start of this human-applied trial. 17) A person who is sensitive or allergic to food ingredients for this human body application test. 18) A person who is deemed unsuitable for the examination by the Investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AHS(Acute Hangover Scale);Blood alcohol, acetaldehyde concentration (hourly concentration, Cmax, Tmax, AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event;Clinical pathology test (hematologic/hematochemical test, urine test);Vital signs (blood pressure, pulse) | — |
Countries
Korea, Republic of
Contacts
Public ContactCHAE MIN BAEG
Global Medical Research Center
Outcome results
None listed