Nicotine Patch - Bioequivalence Study

Study Overview
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Brief Summary
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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

Conditions
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Healthy Smokers

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subject aged 18 to 45 years (inclusive) Current Smoker of >or = 5 and < or = to 15 cigarettes/day Fagerström score < or =5 at selection Absence of any clinically significant abnormal findings at physical examination, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion. Exclusion Criteria: Presence of any significant medical findings 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 safety assessment of a 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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Male

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: Treatment-Sequence 1<br>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. | Drug: Test treatment : V0116 transdermal patch<br> <br> Drug: Reference treatment : Nicotine transdermal patch<br> <br> |
| Other: Treatment-Sequence 2<br>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. | Drug: Test treatment : V0116 transdermal patch<br> <br> Drug: Reference treatment : Nicotine transdermal patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 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