Healthy Smokers
Conditions
Keywords
Smoking cessation, Nicotine, Tobacco Use Disorder, Central Nervous System Agents
Brief summary
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
Interventions
DRUGTest treatment : V0116 transdermal patch
DRUGReference treatment : Nicotine transdermal patch
Sponsors
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
France
Outcome results
None listed