Nicotine Patch - Bioequivalence Study
Phase 1
Completed
- Conditions
- Healthy Smokers
- Registration Number
- NCT02089308
- Lead Sponsor
- Pierre Fabre Medicament
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 74
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method