Clinical Studies

    Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

    First posted
    Dec 12, 2017
    Identifier
    NCT03369340
    Publication Site URL
    Topic
    Official Title

    A Single-center, Open-label, Randomized, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile, Pharmacodynamics, Safety and Tolerability of Four P3P Variants in Smoking Healthy Adult Subjects

    Brief Summary

    This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

    Summary

    Recruitment: Completed 

    Study Results: Available

    Enrollment: 19

    Study Type: Interventional

    Other IDs: P3P-PK-01-CH

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