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

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      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. Our RRPs are smoke-free products that produce an aerosol that contains far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.