None listed
Conditions
Interventions
Intervention1: PartySmart Chews Active/Placebo: Arm A: Active/Placebo Chews â?? Subject will receive two soft chews before the beginning of the alcohol consumption between 30 minutes to maximum 1 hour
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males aged between 20-45 years, weighing more than 45 kgs 2Subject who used to drink alcohol regularly (social drink not alcohol abuse) and is willing and able to comply with the alcohol consumption requirements and overnight stay as per the study requirements 3.Subjects judged by the Investigator to be in general good health based on medical history. 4.Subject understands the study procedures and signs the consent forms providing informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1.Subject suspected for drug or alcohol abuse 2.A medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 3.Subjective sleep duration of less than 3 hours in the night before the test 4.Caffeine, nicotine or alcohol on the day (from midnight) of the test 5.Use of psycho-active drugs during the past 30 days or any treatment that might interfere with the evaluation of the test drug 6.Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450 7.Any clinically significant disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, neurological and or psychiatric disorder etc.) 8.Known hypersensitivity to any of the ingredients of the study drugs 9.Participation in any other clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the blood alcohol and acetaldehyde levels 2.Clinical symptoms related to alcohol consumption 3. Assessment of Alcohol Hangover Questionnaire (AHQ) Timepoint: 12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse effects. Timepoint: 12 Hours | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan
The Himalaya Drug Company
Outcome results
None listed