A study to assess the nicotine uptake of three oral nicotine products in healthy adult smokers

INTERVENTION: Test Product: Nicotine Pouch, 4 mg Reference Product 1: Nicotine Gum, 4 mg Reference Product 2: Nicotine Lozenge, 4 mg Eligible subjects will undergo a training session on how to correctly administer the different nicotine products within 36 to 24 hours prior to the first product administration. Following successful completion of the training session, subjects will be randomized to receive 1 of 6 treatment sequences, where each of the 3 different nicotine products will be administered in 3 sequential periods. In each study period, a product containing 4 mg of nicotine will be administered orally in the morning, following a minimum of an 8‐hour overnight fast. For each treatment sequence, the product administrations will be separated by at least 24 hours (between the start of product administrations). PK blood samples will be collected up to 12 hours post dose for each period. PK blood samples will be collected at 0, 5, 10, 20, 30, 40, 50 min and 1, 1.25, 2, 3, 4, 5, 6, 8, 9, 10, 11, and 12 hours. CONDITION: Oral nicotine use ; Not Applicable PRIMARY OUTCOME: ; Measured by PK blood samples will be collected at 0, 5, 10, 20, 30, 40, 50 min and 1, 1.25, 2, 3, 4, 5, 6, 8, 9, 10, 11, and 12 hours:; Cmax and AUC0‐T of nicotine; SECONDARY OUTCOME: Bioequivalence of Test product compared to Reference products within the 80.0 to 125.0% bioequivalence range measured as above. INCLUSION CRITERIA: Current inclusion criteria as of 20/07/2020: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy adult male or female 4. If female, meets one of the following criteria: 4.1 Is of childbearing potential and agrees to use two of the accepted contraceptive regimens from at least 28 days prior to the first study product administration through to at least 30 days after the last dose of study product. An acceptable method of contraception includes one of the following: ‐Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) ‐intrauterine device (with or without hormones) ‐Barrier methods of contr