Smoking Clinical Trial
Official title:
User Acceptability of a Nicotine Lactate Delivery System Relative to the VUSE e-Cigarette System and Combustible Cigarette Comparators
This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with their own brand of CC or the VUSE e-cigarette system.
The total duration of the study for an individual subject will be between 3 and 8 weeks,
including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE
e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the
preference evaluation session (subjects will be given the choice of using ad libitum the P3L
or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive
safety follow-up period.
The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will
be evaluated as well as the safety and tolerability of the P3L.
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