Nicotine Patch Bioequivalence Study

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Smokers

Intervention / Treatment
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* Drug: V0116 transdermal patch (Test treatment )
* Drug: Nicotine transdermal patch (Reference Treatment )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subject aged 18 to 45 years (inclusive) Current Smoker of >or = 5 and < or = 15 cigarettes/day Fagerström score < or =5 at selection Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram 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) 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 Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1<br>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. | Drug: V0116 transdermal patch (Test treatment )<br> <br> Drug: Nicotine transdermal patch (Reference Treatment )<br> <br> |
| Other: Sequence 2<br>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. | Drug: V0116 transdermal patch (Test treatment )<br> <br> Drug: Nicotine transdermal patch (Reference Treatment )<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents