Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000419-94 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niquitin® Fresh Mint 4 mg | Active Comparator |
| |
| V0118 - B mg | Active Comparator |
| |
| V0474 - C mg | Experimental |
| |
| V0474 - B mg | Experimental |
| |
| V0474 - A mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0474 - A mg | Drug | Single oral administration |
| |
| V0474 - B mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 time points up to 6h after oral administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening up to Day 5 |
| Acceptability questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | France |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Single oral administration |
|
| V0474 - C mg | Drug | Single oral administration |
|
| V0018 - B mg | Drug | Single oral administration |
|
| Niquitin® Fresh Mint 4 mg | Drug | Single oral administration |
|
Quantitative and qualitative descriptive analysis of the scores reported by treatment and assessment time |
| Up to complete lozenge dissolution, about 30 minutes (4 times) |
| D001523 |
| Mental Disorders |