A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers

Inclusion Criteria

• Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Healthy participants which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure, respiratory rate, oral body temperature and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
• Body Mass Index (BMI) of 19 to 27 Kilogram per meter square (kg/m2), inclusive; and a total body weight >50 kg (110 pounds [lbs]).
• Female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female participants who are not of childbearing potential must meet at least one of the following criteria: a) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state. b) Have undergone a documented hysterectomy and/or bilateral oophorectomy.
• Participant admits to having smoked commercially available cigarettes daily for the preceding 12 months and to routinely smoking his or her first cigarette more than 30 minutes upon awakening. Brief periods of non-smoking (e.g. due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the PI (Principal Investigator).

Exclusion Criteria

• Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Participants who are GSK employees directly involved in the conduct of the study.
• Participation in other studies involving investigational drug(s) within 30 days prior to first dose and during study participation.
• Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the Participant inappropriate for entry into this study.
• Pregnant female Participants.
• Breastfeeding female Participants.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
• Participant has used any nicotine replacement therapy within 21 days prior to the first study session.
• Participant has used chewing tobacco, tobacco products or electronic cigarettes other than cigarettes within 21 days of Visit 1.
• Use of prescription or non-prescription drugs and dietary supplements within two weeks or 5 half-lives, whichever is longer, prior to the first dose of investigational product until the end of the study. Allowed treatments are: Systemic contraceptives and hormone replacement therapy, as long as female Participant is on stable treatment for at least 3 months and continues treatment throughout the study. Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.
• History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ou