CompletedInterventionalPhase 1Updated Mar 21, 2024
Nicotine Patch - Multidose Bioequivalence Study | NCT01658215 | Trialant
CompletedInterventionalPhase 1Updated Dec 11, 2012
Nicotine Patch - Multidose Bioequivalence Study
ClinicalTrials.gov ID
NCT01658215
Lead Sponsor
Pierre Fabre MedicamentINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
43Actual
Last Update Posted
Dec 11, 2012Estimated
Start Date
Aug 2012
Primary Completion Date
Sep 2012Actual
Completion Date
Sep 2012Actual
Brief Summary
The purpose of this study is to compare the relative bioavailability of nicotine following repeated applications of a new transdermal formulation to that of a reference formulation.
Up to day 7
Healthy Smokers
V0116 transdermal patch (Test treatment )
Nicotine transdermal patch (Reference treatment )
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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