Pharmacokinetic analysis of nicotine when using non-combustion inhaler type of tobacco product in Japanese adult male smokers

Abstract

In a clinical study, the pharmacokinetics of nicotine were investigated using the prototype of a non-combustion inhaler type of tobacco product (PNCIT) with comparison to a 1mg tar conventional cigarette (CC). The study was conducted in 12 healthy adult Japanese male smokers with an open-label non-randomized design to make an intra-subject comparison of the use or smoking of these products. Subjects used a single piece of PNCIT with 80 aspirations or smoked a CC with 10 puffs every hour, for a total of 12 PNCITs or CCs on each study day. Under this study regimen, the steady state plasma nicotine concentration was not significantly different between the test tobacco products. The time to reach the maximum plasma nicotine concentration was longer for PNCIT compared to CC, suggesting that nicotine delivered from PNCIT was absorbed primarily in the upper airway, not in the pulmonary sites as cigarette smoking. The relative bioavailability of nicotine for PNCIT compared to CC was 0.92±0.32, indicating similar nicotine bioavailability for both forms. The difference in the elimination half-lives between the test products was not significant, suggesting that the elimination of nicotine from blood is not affected significantly by the difference in the nicotine absorption sites.