Nicotine Patch Bioequivalence Study
Overview
- Phase
- Phase 1
- Intervention
- V0116 transdermal patch (Test treatment )
- Conditions
- Healthy Smokers
- Sponsor
- Pierre Fabre Medicament
- Enrollment
- 28
- Primary Endpoint
- Pharmacokinetic profile
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Sequence 1
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.
Intervention: V0116 transdermal patch (Test treatment )
Sequence 1
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.
Intervention: Nicotine transdermal patch (Reference Treatment )
Sequence 2
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.
Intervention: V0116 transdermal patch (Test treatment )
Sequence 2
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.
Intervention: Nicotine transdermal patch (Reference Treatment )
Outcomes
Primary Outcomes
Pharmacokinetic profile
Time Frame: Blood samples will be collected on Days 1, 3, 5 and 7
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
Secondary Outcomes
- Clinical safety (reported adverse events)(up to day 9)