Clinical Studies

      Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L

      First posted
      Aug 25, 2015
      Identifier
      NCT02532374
      Publication Site URL
      Topic
      Official Title

      A Single-center, Open-label, Ascending Nicotine Levels Study to Investigate the Nicotine Pharmacokinetic and Pharmacodynamics Profiles, Safety and Tolerability of P3L in Smoking Healthy Subjects in Relation to Nicorette® Inhalator

      Brief Summary

      The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different nicotine levels in smoking healthy subjects in relation to Nicorette® inhalator.

      Summary

      Recruitment: Completed

      Study Results: Available

      Enrollment: 16

      Study Type: Interventional

      Other IDs: P3L-PK-01-NZ

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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. 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.