4 mg Nicotine Polacrilex Gum and Swedish Portion Snus
Condition: Healthy Subjects; Smokers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General
      White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial
      blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8
      hours after administration for determination of nicotine. Mean + SD extracted dose of
      nicotine from each preparation will be estimated. The percentage extracted of the nicotine
      content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg
      chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in
      relation to the dose following the 4 mg Nicorette chewing gum will be calculated.
      Self-reports of subjective effects will be obtained up to 30 minutes after the test product
      is administered using a 100 mm visual analogue scale (VAS) anchored with "not at all" to
      "extremely". Study hypothesis is that Cmax and AUC of Nicorette 4 mg chewing gum and Swedish
      snus are similar.
    

Detailed description: 
      Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General
      White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum. Serial
      blood samples are drawn before (0), 2, 4, 8, 16, 24, 30, 45, 60 minutes, 1.5, 2, 4, 6 and 8
      hours after administration for determination of nicotine. Mean + SD extracted dose of
      nicotine from each preparation will be estimated. The percentage extracted of the nicotine
      content will be calculated. Cmax and Tmax will be estimated. A comparison to Nicorette 4 mg
      chewing gum will be made. The dose absorbed into the systemic blood circulation (AUC) in
      relation to the dose following the 4 mg Nicorette chewing gum will be calculated.
      Self-reports of subjective effects will be obtained up to 30 minutes after the test product
      is administered using a 100 mm visual analogue scale (VAS) anchored with "not at all" to
      "extremely".

      The subjects are male and female smokers, smoking a minimum of 7 cigarettes per day. They
      should have no history of cardiac, kidney or hepatic disease, alcohol abuse or drug
      dependence. A physical examination including ECG and blood pressure should give no evidence
      of disease. No abnormalities should be found in a routine laboratory screening.

      The subjects are requested not to smoke or to use any other form of nicotine containing
      products from 8 p.m. the day before each session until the last blood sample in each session.
      Previous experience has shown that subjects that have abstained from smoking for 12 hours
      have a plasma nicotine value of <4 ng/ml. A value >4 ng/ml prior to start of administration
      should lead to exclusion from statistical analysis. The subjects must be fasting overnight
      from 12 p.m. the day before each session. No food and drink are allowed from 15 minutes prior
      to and until 60 minutes after drug administration.
    

Intervention name(s): Nicotine; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine pouch, 2.2 mg, single dose, 30 minutes; Chewing Gum, 4 mg, single dose, 30 minutes
Other intervention name(s): General Onyx 1 g portion snus; General White 1g portion snus; Nicorette 4 mg chewing gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Nicotine Polacrilex chewing gum versus Swedish Snus