Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06883760
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-60 years old
* BMI: 18-25 kg/m2
* Healthy adults with experience of being drunk, fully understanding the experimental plan, and voluntarily agreeing to participate
* Able to tolerate a certain amount of alcohol (calculated as 60 kg, about 60 mL of 40-proof liquor)
* Must be able to swallow tablets
Exclusion Criteria:
* People who are very intolerant to alcohol, with aldehyde dehydrogenase activity of 2%
* People with a history of allergic reactions or clinical allergic reactions to drugs, alcohol, products or other ingredients
* People who have taken drugs that induce and inhibit drug metabolizing enzymes, such as barbiturates, within one month from the date of the screening test
* People who have taken drugs that affect the results of clinical trials (alcohol metabolism) (aspirin, antipyretics, anti-inflammatory drugs, analgesics, antibiotics, herbal medicines, oral steroids, hormones, etc.) within 1 month from the screening population
* People who have taken drugs, products and functional foods that affect the intestines (such as probiotics, yogurt, etc.) within 10 days before the test
* People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test
* People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test. Those who have taken products that affect the test results, such as products or drugs that relieve alcohol, etc.
* Those who suffer from severe acute or chronic diseases such as cardiovascular disease, metabolic disease, hepatobiliary disease, pancreatic disease, muscle disease, nervous system disease, mental disorder, endocrine disease, immune disease, kidney disease, malignant tumor, lung disease and other diseases that require treatment
* Those who have received or are receiving clinically significant treatment for gastrointestinal diseases such as gastric or duodenal ulcers
* Those who have donated blood within 2 months from the date of screening
* Those whose serum AST, ALT or creatine kinase levels are higher than the reference range or twice the serum upper limit, and the creatinine level in the diagnostic test exceeds 2.0 mg/dL
* Those who are considered unsuitable due to diagnostic test results or other reasons.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06883760
Study Brief:
Protocol Section:
NCT06883760