Effect PartySmart Variants in alcohol subjects.
- Registration Number
- CTRI/2021/03/032236
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in the blood alcohol and acetaldehyde levels <br/ ><br>2.Clinical symptoms related to alcohol consumption <br/ ><br>3.Assessment of Alcohol Hangover Questionnaire (AHQ) <br/ ><br>Timepoint: 12 hours
- Secondary Outcome Measures
Name Time Method Incidence of adverse effects. <br/ ><br> <br/ ><br>Timepoint: 12 Hours