Clinical trial for the evaluation of the efficacy and safety of DuolacProAP 4 on the reduction of blood acetaldehyde and alcohol after alcohol consumptio
- Conditions
- Not Applicable
- Registration Number
- KCT0005361
- Lead Sponsor
- Cell Biotech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 54
1) Adult male over the age of 19 and under 65 at the time of the screening test
2) Those who have experienced hangover after drinking
3) Those with a body mass index (BMI) of 18 to 25 kg / m2
4) After hearing the detailed explanation of this human application test and fully understanding it, the person who voluntarily decides to participate and agrees in writing to observe the precautions
1) ALDH2 genotype homozygote type (ALDH2 * 2 / * 2)
2) A person who has a clinically significant hypersensitivity reaction or has a history of drugs, alcohol, human application test products, or ingredients.
3) A person who has taken drugs that induce and inhibit drug metabolism, such as barbital drugs, within 1 month from the screening test date
4) Drugs that are expected to affect clinical results such as alcohol metabolism within one month from the screening test date (drugs such as aspirin, drugs that have a risk of gastrointestinal bleeding, antipyretic analgesics, anti-inflammatory drugs, antibiotics, herbal medicines, oral steroids, hormones, etc. )
5) Those who have taken drugs, products and functional foods that are thought to affect the intestines, such as probiotics, lactic acid bacteria-containing beverages (e.g. yogurt), dairy products (e.g. cheese) within one month from the screening test date.
6) Those who have taken drugs, products, and health functional foods that are thought to affect the stomach and liver, such as milk thistle (silimarin) and licorice extract, within one month from the screening test date.
7) Those who have taken other drugs, products, and health functional foods that are considered unsuitable for participation in research by other test takers, such as other hangover-relieving products
8) A person who drinks excessively within one week from the screening test date.
9) Severe acute or chronic cardiovascular disease, metabolic disease, liver and biliary system disease, pancreatic disease, muscle disease, neurological disease, mental disease, endocrine system disease, immune disease, kidney disease, malignant tumor, lung requiring treatment People with diseases and other diseases
10) Patients with clinically significant gastrointestinal diseases such as gastric ulcer and duodenal ulcer or being treated
11) Persons with a history of gastrointestinal disorders (eg Crohn's disease) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of human application test products.
12) Those who have had antipsychotic medication within 2 months from the screening test date
13) People with or have a history of alcoholism or substance abuse
14) Those who participated in other human application tests and clinical trials within 3 months from the screening test date (except in the case where there was no in-house administration of drugs or food (injection, intake, insertion, etc.) as a simple observational study)
15) Those who donated whole blood within 2 months from the screening test date, or who donated components within 2 weeks
16) A person who shows the following results in a diagnostic test
? AST, ALT> 2 times the upper limit of the reference range
? Serum creatinine> 2.0 mg / dl
?Creatine kinase> 2 times the upper limit of the reference range
17) A person who is determined by the test manager to be unsuitable for participation in the study due to other reasons, including the results of diagnostic tests and medical tests
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acetaldehyde in the blood after alcohol consumption;Blood alcohol after alcohol consumption
- Secondary Outcome Measures
Name Time Method Scores for symptoms of hangover after alcohol consumption;Liver function indicators;Blood sugar index