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

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