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

      PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts to develop and assess products that have the potential to reduce individual risk and population harm associated with tobacco use. This site is 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 for advertising or marketing. It is not intended for use by consumers.

      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.