A Clinical Study To Evaluate The Effect Of Nicotine Polacrilex Gum USP 2 mg In Tobacco Users.
- Registration Number
- CTRI/2023/10/058889
- Lead Sponsor
- ITC Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
1. Subjects should be 18 to 55 years of age (both years inclusive).
2. Capable and willing to give informed written consent and to adhere to the study requirements.
3. Subjects able to read, write and able to communicate effectively.
4. Body Mass Index (BMI) between 18.50–29.99 Kg / m2 (both inclusive) and with minimum weight of 50 kg.
5. Healthy individuals as evaluated by personal history, medical history and general clinical examination.
6. Absence of significant disease
7. Clinically not significant abnormal laboratory values or laboratory evaluation, medical history or physical examination judged by investigator.
8. Normal biochemical, hematological and urinary parameters or with abnormality considered to be clinically not significant and performed within 21 days prior to check-in for the first period of the study.
9. Have a normal 12 lead ECG or with an abnormality considered to be clinically not significant.
10. Healthy volunteer with systolic blood pressure not less not less than 100 mmHg and not more than 130 mmHg and diastolic blood pressure not less than 70 mmHg and not more than 84 mmHg.
11. Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and Syphilis.
12. Negative urine test for drugs of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in during each period).
13. Negative Urine test for alcohol consumption (to be performed on the day of check-in during each period).
14. No known food allergy or intolerance.
15. No medications known to affect study drug tolerance.
16. Tobacco using regularly (at least 5 days a week) for at least 12 months preceding check in day, confirmed by Fagerstorm test for Nicotine Dependence. Volunteer with moderate to high dependence to nicotine will be included.
17. Subjects having a first tobacco consumption post 30 minutes of awakening in a daily life.
18. Subjects who avoid cigarettes and tobacco containing products or nicotine containing product for atleast 12 hours prior to dosing.
19. Have an intent to quit
20. Subject with moderate to high Fagerstrom Test score prior to dosing will be dosed.
The subjects will be excluded based on the following criteria:
1. Subjects incapable of understanding the informed consent.
2. Hypersensitivity or allergic to drugs under investigation.
3. Subjects with history of epilepsy or seizures or convulsions or treatment with anti-epileptic medicines.
4. Subjects with history of central nervous system disorders like encephalopathy, optic neuropathy or neuritis, peripheral neuropathy.
5. Hepatic Impairment.
6. Subjects with blood dyscrasias, heart failure, hepatic failure, H. pylori infection, renal
impairment.
7. History of treatment with medicines containing alcohol, propylene glycol as ingredients and other medicines
8. Alcohol consumers, intake of alcohol 07 days prior to check-in and/or found positive in Urine test for alcohol consumption during check-in of each period.
9. History of any major surgical procedure in the past 3 months.
10. History of diabetes mellitus, tuberculosis and systemic hypertension.
11. History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine,metabolic, psychiatric, neurological or hematological systems, judged to be clinically significant.
12. Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study.
13. Moth ulcers and mouth problems.
14. History of asthma.
15. History of peptic ulcer disease
16. History of any medical disorder that is of significance in the investigator’s opinion.
17. History of any drug abuse.
18. History of hypersensitivity to study medications and related drugs e.g., Sulpha drugs, Heparin or excipients in the formulation (if the excipients are known).
19. History of allergy to vegetables and / or food substances and / or any other manifestations
suggestive of hypersensitivity reactions.
20. Consumption of grapefruit juice and /or grapefruit at least 48-hours prior to Period I checkin.
21. Intake of any prescription medications within 14 days prior to check-in and throughout the study, and/or over-the counter (OTC) & herbal drugs within 7 days prior to check-in and / or intake of any drug in the past for long term that could affect the kinetics or dynamics of study medications in view of investigator.
22. Medications known to affect nicotine tolerance.
23. Subjects with clinically significant abnormal values of laboratory parameters.
24. History of habituation to or consumption of caffeine and /or xanthine products within 36 hours prior to dosing and inability to withhold the intake during the in house stay.
25. An unusual diet for whatever reason e.g. low sodium diet, for four weeks prior to study initiation and throughout subject’s participation in the study.
26. Known hypersensitivity or idiosyncratic reaction to study drugs, its excipients or similar classes of drugs.
27. Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions.
28. The presence of disease or drugs which influence digestion and absorption of nutrients.
29. The use of caffeine, heart related medications or antipsychotics (all of which have major effects on nicotine metabolism).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rges for Tobacco consumption will be assesed using scoring on a 100 mm visual analogue scale (VAS) <br/ ><br>Timepoint: at time points-10 (pre dose),-3 (pre dose), 2, 3, 5, 7, 10, 15, 30, 45 minutes and 1, 2, 3, 4, 5 hours after treatment administration.
- Secondary Outcome Measures
Name Time Method This study is a single dose study hence treatment outcome is not captured in the protocol, secondary objective as per the protocol is Relief From Urge For Tobacco Consumption, ScoreTimepoint: Relief from Tobacco use will be scored on a 100 mm visual analogue scale (VAS) at -10,-3, 2, 3, 5, 7, 10, 15, 30, 45 min & 1, 2, 3, 4, 5 hours after treatment administration