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

    Related Publications

    Misunderstanding nicotine delivery: Discussion on nicotine pouches

    Nicotine

    AeroSolved: Wall Boundary Conditions for Liquid Multispecies Aerosol Deposition at Transient and High-Humidity Flows

    Aerosol Physics

    Bridging Approaches to Facilitate Innovation: Building an Approach for Heated Tobacco Products from Case Studies in the Food and Drug Domains a Comparative Review

    Aerosol Chemistry;Pre-clinical Toxicology

    A Comparative Assessment of the FDA List of 93 HPHCs in Aerosol Generated by Tobacco Heating System 2.2 versus 3R4F Reference Cigarette Smoke

    Aerosol Chemistry;Pre-clinical Toxicology

    Monoamine Oxidase Inhibitors Present in Tobacco Modulate Dopamine Balance Via the Dopamine Transporter

    Nicotine

    Tobacco Use, Risk Perceptions, and Characteristics of Adults Who Used a Heated Tobacco Product (IQOS) in the United States: Cross-Sectional Survey Study

    Perception and Behavior;Smoke-free products

    PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
    ​
    Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.