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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