The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Single oral administration
Single oral administration
Single oral administration
Eurofins Optimed
Gières, France
Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers
Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers by measuring Maximum Plasma Concentration (Cmax), Time of Maximum Concentration (Tmax) , Area under the nicotine plasma concentration curve (AUC0-t), for each test and reference formulations
Time frame: 12 time points up to 6h after oral administration
Clinical safety (reported adverse events)
Safety by evaluating the number of subjects with emergent adverse events and changes from baseline to end of study in vital signs, Electrocardiogram (ECG) and clinical laboratory parameters.
Time frame: Screening up to Day 5
Acceptability questionnaire
Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time
Time frame: Up to complete lozenge dissolution, about 30 minutes (4 times)
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Single oral administration
Single oral administration