At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes
In Brief
A clinical study evaluating CA35, CM35, and 1 other intervention for Nicotine Vaping and 2 related conditions. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design. This study is exploratory and there is no pre-specified hypothesis to be tested.
Study Details
Timeline
Interventions
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Subjects' preferred brand of commercially available, regular or mentholated cigarettes