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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006212-32 | EudraCT Number |
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The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.
4 single 24hour applications separated by 48hour intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals. Each patch will be applied for 24h. |
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| Sequence 2 | Other | After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals. Each patch will be applied for 24h. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0116 transdermal patch (Test treatment ) | Drug |
| ||
| Nicotine transdermal patch (Reference Treatment ) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile | Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations | Blood samples will be collected on Days 1, 3, 5 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety (reported adverse events) | General and local safety by evaluating the number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram, haematology and biochemistry | up to day 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | France |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Drug |
|
| D001523 |
| Mental Disorders |