Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2014-03-31
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nicotine Patch Bioequivalence Study
NCT01658202
Nicotine Patch - Multidose Bioequivalence Study
NCT01658215
Nicotine Patch Safety Study
NCT01655082
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
NCT01702519
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
NCT01238640
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment-Sequence 1
Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment -Sequence 1 : Period 1 (test drug) + period 2 (reference)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.
Test treatment : V0116 transdermal patch
Reference treatment : Nicotine transdermal patch
Treatment-Sequence 2
Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treament periods.
Treatment-sequence 2 : Period 1 (reference) + period 2 (test drug)
The duration of each treatment period will be 3 days. Each patch will be applied for 24 hours.
Test treatment : V0116 transdermal patch
Reference treatment : Nicotine transdermal patch
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Test treatment : V0116 transdermal patch
Reference treatment : Nicotine transdermal patch
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or safety assessment of a transdermal patch
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pierre Fabre Medicament
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gières, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-005290-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V00116 TD 1 06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.