None listed
Conditions
Interventions
Intervention1: Anti-hangover food supplement capsule: Two hours after consumption of dinner will receive IP once a time oral route with 240
2 mL of drinking water. After 30 minutes of ingestion food
Sponsors
MNH BIO Co. Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: A subject fulfilling the following criteria will be included in the present study: Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study Willing to be available for the entire study period and to comply protocol requirements Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age Body mass index in the range of 18.50 29.99 kg per m2 (both inclusive) Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis Normal or clinically non-significant 12 lead ECG recording Subjects who consume alcohol occasionally Subjects who consume alcohol regularly and moderately Subjects who experienced of hangover Non-smokers or subjects who have no history of smoking for the last one year prior to check-in Willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to check-in until last sample collection in each study period Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period For female subjects Negative urine pregnancy test during screening and negative serum beta-hCG test at the time of check-in of each study period
Exclusion criteria
Exclusion criteria: A subject with the following criteria will be excluded from the study: Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs; Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction; Subject on Insufficiency alcohol metabolism, Diabetes, Hypertension, Gall stone, Pancreatitis, Gout, Tuberculosis, Bleeding GI tract, surgical operation, and patients with Kidney, liver (Hepatitis B, C, and alcoholic hepatic insufficiency), respiratory, GI tract, mental disorder; Any major illness or hospitalized within 90 days prior to the first check-in; Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study; Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study; Subject abstain from alcohol or less drinking alcohol than one time a month; Use of any food supplement or medicine can effect on alcohol metabolism; Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study; History or presence of significant gastric and/or duodenal ulceration; Difficulty in swallowing tablets or capsules; Use of any recreational drug or history of drug addiction; Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in; Positive urine alcohol and urine drug of abuse tests during check-in of each study period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Assesment: Supplement Antihangover Food is effective in preventing the signs and symptoms of alcohol induced hangover Subjective Assessment: Alcohol Hangover Severity Scale (AHSS) : 0-10 Score and Acute Hangover Scale Blood concentration of alcohol: by GC Blood concentration of Acetaldehyde: by GCTimepoint: 1.Evaluation & Questionnaire evaluation will be performed within 1.00 administrations of anti- hangover food supplement and at 24.00 hours & 12.00 hours post-administration of alcohol 2. Safety Laboratory Investigations: During Screening and at end of study. 4. Blood samples will be drawn at 0.000 (within 2.00 hours prior to dosing), 0.250, 0.500, 1.000, 2.000, 4.000, 6.000 and 15.000 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Yashvant Khaire
Raptim Research Pvt. Ltd.,
Outcome results
None listed