Oral Tolerability Of Two Nicotine Dosage Forms
Condition: Healthy Volunteer Smokers
Intervention: Nicotine; Nicotine
Intervention description: Marketed nicotine replacement therapy formulation; Nicotine prototype
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine Tolerability NRT

Summary:

      This study is to evaluate the oral tolerability of a nicotine prototype
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age:Males and females aged at least 18 years.

          -  Smoking status: a.Must have smoked 5 to 20 cigarettes per day for the previous 12
             months. b.Must be motivated to quit smoking upon randomization into study.

          -  Contraception:Females of childbearing potential who have been, in the opinion of the
             investigator, practicing a reliable method of contraception for at least two months
             prior to study participation and must agree to remain on an acceptable method of
             contraception while participating in the study period using the study medication.
             Acceptable methods of contraception are hormonal birth control, intrauterine device,
             double barrier methods, vasectomized partner or abstinence.

          -  Oral health:Must have good oral health (in the opinion of the Investigator) with no
             clinically significant oral pathology at screening.

          -  General health:Must have good general health (in the opinion of the Investigator) with
             no clinically significant and relevant abnormalities of medical history on physical
             examination at screening.

          -  Compliance:Understands and is willing, able and likely to comply with all study
             procedures and restrictions.

          -  Consent:Demonstrates understanding of the study and willingness to participate as
             evidenced by voluntary written informed consent and has received a signed and dated
             copy of the informed consent form.

        Exclusion Criteria:

          -  Pregnancy:Women who are known to be pregnant or who are intending to become pregnant
             over the duration of the study. Females of child-bearing potential will be required to
             undergo a urine pregnancy test which must be negative.

          -  Breast-feeding:Women who are breast-feeding.

          -  Nicotine use: a.Is unable/unwilling to stop using forms of tobacco. b.Is
             unable/unwilling to stop using other nicotine replacement therapy.

          -  Disease:Has a medical history, which in the opinion of the Investigator, would
             jeopardize the safety of the subject or impact the validity of the study results, e.g.
             known history of heart disease, recent myocardial infarction or cerebrovascular
             accident (i.e. within 12 weeks prior to the first study session), unstable angina,
             severe cardiac arrhythmia, diabetes or peptic ulcer.

          -  Oral condition: a.Has history of oral surgery (including extractions) within four
             weeks, operative dental work within seven days, or a presence of any clinically
             significant oral pathology (as determined by the Investigator) including lesions,
             sores or inflammation which would interfere with assessments. b.Has fixed retainers,
             orthodontic appliances, or either maxillary and/or mandibular dentures or other
             appliances which may interfere with the placement or wearing of the product. c.Has
             current or recurrent disease that could affect the site of application, the action,
             absorption or disposition of the study treatment, or clinical assessment. d.Has severe
             gingivitis, periodontitis or rampant caries, as diagnosed by the investigator. e.Has
             the presence of oral or peri-oral ulceration including herpetic lesions at the time of
             baseline (subjects with these lesions may be re-examined at a subsequent appointment
             and may be able to be admitted at a later date if the ulceration or herpetic lesion
             heals). f.Has elective dentistry scheduled during the study duration.

          -  Allergy/Intolerance: a.Has a known or suspected intolerance or hypersensitivity to the
             study materials (or closely related compounds) or any of their stated ingredients.
             b.Presence of a genetic deficiency with an inability to metabolize aspartame or
             phenylalanine or has been diagnosed with phenylketonuria.

          -  Clinical Study/Experimental medication: a.Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit at the start
             of the study. b.Previous participation in this study.

          -  Substance abuse: a) Current or recent (within two year of screening) alcohol or other
             substance abuse. b) Positive alcohol breath screen. c) Positive urine drug screen for
             cannabinoids, amphetamine, cocaine, ecstasy, methamphetamine or morphine.

          -  Urine glucose:Positive glucose urine screen.

          -  Personnel: a.Is an employee of the sponsor or the study site. b.Is a member of the
             same household as another subject in this trial.