â??A double-blind, placebo-controlled, comparative clinical study followed by an Open-label extension study, to evaluate the efficacy and safety of PartySmart Soft Chewsâ??

Himalaya Wellness Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年5月30日

试验速览

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•1.Male and female subjects aged between 20-50 years, weighing more than 45 kgs.
•2. Subjects who used to drink alcohol regularly (social drink, but not alcohol abuse) and is willing and able to comply with the alcohol consumption, blood withdrawal 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. Subjects understand the study procedures and sign the informed consent forms to participate in the study

•1 Subjects 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 every study period.
•4. Caffeine, nicotine on the day (from midnight) of the every study Period.
•5. Alcohol consumption within 7 days of enrollment in the study
•6. Use of psycho-active drugs during the past 30 days or any treatment that might interfere with the evaluation of the test drug.
•7. Subjects taking any drug known to interact with benzodiazepines and other drugs, e.g. antiepileptics, antihistamines, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450.
•8. Subjects suffering from 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.).
•9. Known hypersensitivity to any of the ingredients of the study drugs.
•10. Participation in any other clinical trial within the past 30 days.

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