This is a multi-center, randomized, controlled, partially blinded study to assess the pharmacokinetics and comparative bioavailability of nicotine from two variants of NP2 (4 and 6 mg) in comparison with Loz-4mg and Gum-4mg in adult cigarette smokers. The subjects will be blinded to the randomized sequence and will be blinded to the variants of NP2 they will receive. The study will be conducted with 4 periods and 4 sequences in a Williams design (crossover).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
NP2-4 mg is a new product containing tobacco-derived nicotine.
NP2-6 mg is a new product containing tobacco-derived nicotine.
The Loz-4mg reference product is a commercially available 4mg nicotine lozenge.
The Gum-4mg reference product is a commercially available 4mg nicotine gum.
Pharma Medica Research Inc.
Toronto, Ontario, Canada
Syneos Health Clinique Inc.
Québec, Canada
Maximum Plasma Concentration [Cmax]
To measure Cmax following use of the investigational products and reference products
Time frame: Measured from start of product use to 24 hours
Area under the observed concentration-time curve (AUC) from start of product use (T0) to timepoint of last quantifiable concentration [AUC0-last] and extrapolated to infinity [AUC0-infinity]
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use
Time frame: Measured from start of product use (T0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.
Ratio of [AUC0-last] and [AUC0-infinity]
To measure the ratio of \[AUC0-last\] and \[AUC0-infinity\]
Time frame: Measured from start of product use to 24 hours
Time to the observed maximum concentration [Tmax]
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Time frame: Measured from start of product use to 24 hours
Elimination rate constant [kel]
To measure the fraction of nicotine eliminated per unit of time, following use of the investigational products and reference products
Time frame: Measured from start of product use to 24 hours
Half-life of nicotine [t1/2]
To measure the half-life of nicotine, following use of the investigational products and reference products
Time frame: Measured from start of product use to 24 hours
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