Part two: an unblinded, parallel, randomized study to assess nicotine pharmacokinetics of four Vuse Solo ENDS flavors in smokers

We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were colle...

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Bibliographic Details
Published in:Scientific reports 2023-06, Vol.13 (1), p.8894-8894, Article 8894
Main Authors: Keyser, Brian M., Hong, Kyung Soo, DeLuca, Patricia, Jin, Tao, Jones, Bobbette A., Nelson, Paul, Schmidt, Eckhardt, Round, Elaine K.
Format: Article
Language:English
Subjects:
631/443
631/45
692/308
692/53
Confidence intervals
Electronic cigarettes
Humanities and Social Sciences
multidisciplinary
Nicotine
Pharmacokinetics
Plasma
Public health
Science
Science (multidisciplinary)
Smoking
Tobacco
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Summary:We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were collected for PK assessments during a test session. Primary endpoints were baseline-adjusted values of maximum plasma nicotine concentration (C max ) and area under the nicotine concentration-vs-time curve up to 60 min (AUC nic0–60 ). Baseline-adjusted mean C max ranged from 6.53 to 8.21 ng/mL, and mean AUC nic0–60 ranged from 206.87 to 263.52 ng min/mL for all ENDS IPs. Results of geometric mean C max and AUC nic0–60 values were within 95% confidence intervals (CI) among the ENDS IP flavor variants tested.
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-023-35439-3