Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005290-47 | 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
Not provided
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-Sequence 1 | Other | Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods. Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference) The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours. |
|
| Treatment-Sequence 2 | Other | Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods. Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug) The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test treatment : V0116 transdermal patch | Drug |
| ||
| Reference treatment : Nicotine transdermal patch |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | During the third application of each period,12 time points up to 24h after the application | |
| Time to Maximum Concentration (Tmax) | During the third application of each period,12 time points up to 24h after the application | |
| Area under the plasma concentration-time curve (AUC) | During the third application of each period, 12 time points up to 24h after the application |
Not provided
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 |
|---|---|---|---|---|---|---|
| Gières | 38610 | 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
Not provided
| Drug |
|
| D001523 |
| Mental Disorders |