Healthy Smokers
Conditions
Keywords
Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
Brief summary
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.
Interventions
DRUGV0474 - A mg
Single oral administration
DRUGV0474 - B mg
Single oral administration
DRUGV0474 - C mg
Single oral administration
DRUGV0018 - B mg
Single oral administration
DRUGNiquitin® Fresh Mint 4 mg
Single oral administration
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subject aged 18 to 45 years (inclusive) * Current smoker of \< or = 10 cigarettes/day * Fagerström score \< or = 5 * Absence of any clinically significant abnormal finding at physical, ECG, biological examinations in the Investigator's opinion
Exclusion criteria
* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator * Current or recurrent buccal lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers | 12 time points up to 6h after oral administration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical safety (reported adverse events) | Screening up to Day 5 | 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. |
| Acceptability questionnaire | Up to complete lozenge dissolution, about 30 minutes (4 times) | Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time |
Countries
France
Outcome results
None listed