The nicotine pharmacokinetics (PK) of non-combustible tobacco products, including e-cigarettes, have been widely assessed, with lower or similar nicotine exposure reported for most products when compared to conventional cigarettes (CC).

We conducted two clinical studies to evaluate the nicotine PK in U.S. cigarette smokers who used two types of e-cigarettes with several flavour variants.

Study 1 was a single-centre, randomized, open-label, controlled, 6-period crossover study conducted in healthy adult smokers. The primary objective of the study was to evaluate the nicotine PK following a single ad libitum use of cig-a-like e-cigarette (eDNC1.0a) with three flavour variants in comparison to CC, an FDA-approved nicotine gum, and a comparator e-cigarette. A total of 52 subjects were randomized to one of 6 product use sequences, with 52 subjects completing the study. The plasma PK data demonstrated that nicotine exposure using eDNC1.0a was lower than CC and somewhat similar to the comparator e-cigarette and the nicotine gum.

Study 2 was a single-centre, randomized, open-label, controlled, 7-period crossover study conducted in healthy adult smokers. The primary objective of the study was to evaluate the nicotine PK following a single ad libitum use of closed tank e-cigarette (eDNC2.0a) with four flavour variants in comparison to CC, an FDA-approved nicotine oral inhaler, and a comparator e-cigarette. A total of 55 subjects were randomized to one of 14 product use sequences, with 51 subjects completing the study. The plasma PK data demonstrated that nicotine exposure using eDNC2.0a was lower than CC, somewhat lower than the comparator e-cigarette, and higher than the nicotine inhaler.