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Nicotine Patch - Multidose Bioequivalence Study

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.
 
ClinicalTrials.gov Identifier: NCT01658215
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Tracking Information
First Submitted Date  ICMJE July 31, 2012
First Posted Date  ICMJE August 6, 2012
Last Update Posted Date December 11, 2012
Study Start Date  ICMJE August 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2012)
Pharmacokinetic blood samples [ 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
Change History Complete list of historical versions of study NCT01658215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicotine Patch - Multidose Bioequivalence Study
Official Title  ICMJE Not Provided
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Smokers
Intervention  ICMJE
  • Drug: V0116 transdermal patch (Test treatment )
  • Drug: Nicotine transdermal patch (Reference treatment )
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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.

    Interventions:
    • Drug: V0116 transdermal patch (Test treatment )
    • Drug: Nicotine transdermal patch (Reference treatment )
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)
43
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2012)
40
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01658215
Other Study ID Numbers  ICMJE V00116 TD 1 05
2011-006213-33 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre Fabre Medicament
Study Sponsor  ICMJE Pierre Fabre Medicament
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pierre Fabre Medicament
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP