None listed
Conditions
Interventions
Intervention1: Reference Product (R): Paan Masala/Tobacco Mixture (Strength 4g) (Vimal): (Vimal) [Tobacco12.5% Paan Masala (Areca nut, Lime, Catechu, Flavours)-87.5%]
Form â?? Mixture
Manufactured by
Sponsors
Dr Sachin Shivnitwar
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Full I/E Criteria incorporated in Inclusion Exclusion Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess absorption of the Nicotine gums as a nicotine replacement therapy when the 2mg and 4mg nicotine gums when compared with conventional Paan Masala/Tobacco Mixture (R). Timepoint: The concentrations will be compared at the following timepoints: 0.08hrs, 0.17 hrs, 0.25 hrs, 0.33 hrs, 0.42 hrs, 0.50 hrs, 0.58 hrs, 0.67 hrs, 0.83 hrs, 1.00 hrs, 1.50 hrs, 2.00 hrs, 3.00 hrs, 6.00 hrs and 8.00 hours post administration of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the craving scores of four different Nicotine gum formulations (strength-2/4 mg) with Paan Masala/ Tobacco Mixture (R). Also to assess the safety and tolerability of the investigational products as assessed at predose, 1hr and 3hrs post administration.Timepoint: Timepoints: -2.5min, 3.0min, 7.5min, 17.5min, 32.5min, 47.5min, 65 min post administration of the investigational product. | — |
Countries
India
Contacts
Public ContactDr Sunil Chaudhary
Lifepoint Multispecialty Hospital,Pune
Outcome results
None listed