Clinical Studies

    Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it

    First posted
    May 16, 2019
    Identifier
    NCT03953183
    Publication Site URL
    Topic
    Official Title

    A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month

    Brief Summary

    The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.

    Summary

    Recruitment: Completed

    Study Results: Available

    Enrollment: 60

    Study Type: Interventional

    Other IDs: P3P-SE-02-RU

    Related Publications

    Comparison of Abdominal Aortic Aneurysm Growth in Adult Smoking Patients Who Either Switch to IQOS, Continue Smoking, or Quit Smoking

    Clinical

    Systematic review of the relation between smokeless tobacco and cancer of the pancreas in Europe and North America

    Clinical

    Reduced exposure to Harmful and Potentially Harmful Constituents after 90 days of use of Tobacco Heating System 2.2 Menthol in Japan: A comparison with continued cigarette use or smoking abstinence

    Clinical

    Reduced Exposure To Harmful And Potentially Harmful Constituents after 90 Days Of Use Of Tobacco Heating System 2.2 Menthol In Japan: A Comparison With Continued Cigarette Use Or Smoking Abstinence

    Clinical

    Psychometric Evaluation of the mCEQ applied to Cigarettes and Heat-Not-Burn Products in the US and Japan

    Clinical

    Pharmacokinetics Of Nicotine And Subjective Effects Following The Single Use Of A Non-Menthol And Menthol Version Of Tobacco Heating System 2.2 In Two Studies In Japan: A Comparison With Single Use Of A Combustible Cigarette And Nicotine Gum

    Clinical

    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.