None listed
Conditions
Interventions
Group A:Beer A
Group B:Beer B
Sponsors
Dongguan Kanghua Hospital Phase I Clinical Trial Research Center
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Men aged 18 to 45 years (including 18 and 45) who drink alcohol in a healthy manner; 2. Weight: Male subjects should not be less than 50 kg, with body mass index [BMI= weight (kg)/height ^2 (m^2)] in the range of 19.0 ~ 26.0 kg/m^2 (including boundary values); 3. Health status: (1) No history of major diseases such as central system, cardiovascular system, liver, kidney, digestive system, respiratory system, blood system and metabolic disorders; (2) During the screening period, there were no abnormalities in physical examination, 12-lead electrocardiogram, vital signs, blood routine, urine deca, blood biochemistry, coagulation function, hepatitis B surface antigen HBsAg, hepatitis C antibody HCVAb, human immunodeficiency virus antibody HIVAb, treponema syphilis specific antibody T-P and other indicators including laboratory examination or abnormalities judged by the study physician to be clinically insignificant; 4. Behavior habits: (1) Those who are not addicted to tobacco or alcohol and drink no more than 3.5 units of alcohol per day (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine); (2) Agree not to smoke or drink alcohol (except study products) during the stay and within 48 hours prior to the first consumption of study products; (3) Consent to abstain from drinking caffeinated beverages during hospitalization and 24 hours before first consuming the study product; (4) Agree not to eat foods high in sodium (including ham sausage, salted peanuts, beef jerky, etc.), not to drink spirits, wine, soda and other foods associated with elevated uric acid, not to eat eggs, peanuts, cold cereal, skim milk, cheese, brown bread, margarine and non-citrus fruits (associated with decreased blood uric acid level) without authorization from the signing of the notice to the end of the study; 5. Fertile subjects (including male subjects' partners) have no family planning, voluntarily take appropriate and effective contraceptive measures (physical contraception during the study period) and have no sperm donation plans from the signing of the information to 6 months after the study; 6. The subject fully understands the purpose, nature, method and possible adverse reactions of the study, volunteers to be a subject, and signs informed consent prior to the start of any study procedure; 7. Able to communicate well with researchers and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to be allergic to Spartina extract or any component of this product, or have allergic disease or allergic constitution; 2. Poor conditions for vascular puncture, unable to tolerate venipentesis, or have a history of fainting needle and fainting blood, or have known serious bleeding problems that can affect venous blood collection; 3. Patients who had a major disease of clinical significance or underwent a major surgical operation in the 4 weeks prior to the study, or who planned to undergo surgery during the study period; 4. Patients with a history of hypertension or hypotension; 5. Patients with a history of alcoholism; 6. Those who donated or bled more than 400 ml or received blood transfusions or used blood products in the three months prior to the study; 7. Participation in any clinical study and use of study medication within 90 days prior to first consumption of the study product; 8. Any drug containing enzymes that inhibit or induce liver drug metabolism has been used in the 30 days prior to the study (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids; Inhibitors: SSRI antidepressants, cimetidine, omeprazole, diltiazem, macrolides, nitroimidazole, verapamil, fluoroquinolones, antihistamines); 9. Used any drug for various reasons within 14 days prior to the first consumption of the study product, or used Chinese herbal medicine habitually; Patients who had taken antibacterial drugs, central nervous system inhibitors and other drugs within 14 days before first consuming the study product (Common antibacterial drugs such as cefoperazone tablets, ceftriaxone tablets, metronidazole capsules, etc.; Common central nervous system inhibitors include Esazolam tablets, etc.); 10. Had used soft drugs (e.g., ecstasy, KEN powder, meth, etc.) in the 3 months prior to the study or hard drugs (e.g., cocaine, heroin, methamphetamine, etc.) in the 1 year prior to the study; Or those who tested positive for five drugs before the study; 11. Smokers who smoked more than 5 cigarettes per day in the 3 months prior to the study; 12. Patients who consumed excessive amounts of tea, coffee and/or caffeinated beverages daily in the three months prior to the study (average more than 8 cups of 200 mL each), or had consumed xanthine, grapefruit or grapefruit-related citrus fruits (e.g., limes, pomelos) or fruit juices in the two days prior to drinking beer; Or alcohol breath test results greater than 0.0 mg/100mL before study; 13. Patients who have special dietary requirements, cannot abide by the unified diet, or have difficulty swallowing; 14. Patients may be unable to complete the study for other reasons or have other factors that the investigator deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood uric acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood fat; | — |
Countries
China
Contacts
Public ContactZhong Guoping
Dongguan KangHua Hospital
Outcome results
None listed