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Nicotine Patch - Multidose Bioequivalence Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658215
First Posted: August 6, 2012
Last Update Posted: December 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Fabre Medicament
  Purpose

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


Condition Intervention Phase
Healthy Smokers Drug: V0116 transdermal patch (Test treatment ) Drug: Nicotine transdermal patch (Reference treatment ) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: Blood samples will be collected Day 3 and Day 6 ]
    Pharmacokinetic profile of nicotine following a repeated patch applications by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations


Secondary Outcome Measures:
  • Clinical safety (reported adverse events) [ Time Frame: up to day 7 ]
    General and local safety by evaluating the number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram, haematology and biochemistry


Enrollment: 43
Study Start Date: August 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sequence 1

Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treatment periods. The duration of each treatment period will be 3 days.

Each patch will be applied for 24 hours.

Drug: V0116 transdermal patch (Test treatment ) Drug: Nicotine transdermal patch (Reference treatment )
Sequence 2

Subjects will be randomly assigned to one of 2 treatment-sequence groups with 2 treatment periods. The duration of each treatment period will be 3 days.

Each patch will be applied for 24 hours.

Drug: V0116 transdermal patch (Test treatment ) Drug: Nicotine transdermal patch (Reference treatment )

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658215


Locations
France
Rennes, France
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01658215     History of Changes
Other Study ID Numbers: V00116 TD 1 05
2011-006213-33 ( EudraCT Number )
First Submitted: July 31, 2012
First Posted: August 6, 2012
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Pierre Fabre Medicament:
Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action