CompletedInterventionalPhase 1Updated Mar 21, 2024
Nicotine Patch - Bioequivalence Study | NCT02089308 | Trialant
CompletedInterventionalPhase 1Updated Jun 12, 2014
Nicotine Patch - Bioequivalence Study
ClinicalTrials.gov ID
NCT02089308
Lead Sponsor
Pierre Fabre MedicamentINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
74Actual
Last Update Posted
Jun 12, 2014Estimated
Start Date
Mar 2014
Primary Completion Date
May 2014Actual
Completion Date
May 2014Actual
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
Healthy Smokers
Test treatment : V0116 transdermal patch
Reference treatment : Nicotine transdermal patch
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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