To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers

This study will be a single center, randomized, open label, single dose, two‐way crossover in healthy smokers that smoke their first cigarette within 30 minutes of waking. This study will consist of following Visits: Visit 1 (Screening), Visit 2 (Study Period 1), followed by a Washout period and Visit 3 (Study Period 2). This will ensure approximately 29 evaluable participants per treatment arm. Each participant will be treated with a single dose of the two study treatments (test and reference) in a randomized sequence, under fasting conditions. Participants will be confined in the study facility for approximately 60 hours during each study session (for 36 hours pre‐dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. Participants are to abstain from smoking during the confinement periods and be subject to random measurements of expired carbon monoxide (CO) to confirm abstinence. The CO levels must be ≤10 parts per million (ppm) throughout the study session. There will be at least 5‐day and not more than 7‐day clinical furlough period between treatment periods. For each treatment period, the clinical confinement period with restriction of smoking is at least 36 hours prior to dosing.