CTRI/2023/02/049880尚未招募未知
A double blind, randomized, five treatment, five period, five way crossover, investigator initiated, comparative bioavailability and craving assessment study of four different Nicotine gums as test formulations (T1, T2, T3, T4) with Paan Masala/Tobacco Mixture as reference (R) in 20 normal, healthy, adult, human tobacco and pan masala chewers under fasting conditions.
Dr Sachin Shivnitwar0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Healthy male and female volunteers who chew tobacco and/or pan masala at least once daily or more for at least 6 months. 2. Be available to participate for the entire study period and have willingness to adhere to Protocol requirements as evidenced by the written ICF duly signed by the volunteer.3. Be a healthy human subject in the age group between 18 to 45 years (both inclusive) and BMI must be within the range of 18.50 â?? 24.90 Kg/m2 (both inclusive) with minimum body weight 50 kg (both inclusive). 4. Volunteers who score 5 or more on Fagerstrom Nicotine Dependence Scale Smokeless Tobacco (FTND-ST). 5. Have no evidence of underlying disease during screening, medical history and whose physical examination is performed within 28 days prior to commencement of the study. 6. Have screening laboratory values within normal limits or considered by the Investigator to be of no clinical significance.7. Not have alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine,Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year. 8. Agree to abstain from consuming xanthine-containing food products or beverages(chocolates, tea, coffee or cola drinks), tobacco containing products (cigarettes, pan and
- •ghutka etc.) and alcohol containing beverages from 48.00 hrs prior to check in of Period-I and during the entire study except the study medication administered.9. Agree to abstain from grapefruit and grapefruit containing products, Citrus fruits and citrus fruit containing products, apple or pineapple fruit or containing products from 7 days prior to dosing of period I and during the entire study.
- •Full I/E Criteria incorporated in Inclusion Exclusion Form
排除标准
- •Full I/E Criteria incorporated in Inclusion Exclusion Form
研究者
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