Nicotine Patch Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01658202
First received: July 31, 2012
Last updated: December 10, 2012
Last verified: December 2012

July 31, 2012
December 10, 2012
August 2012
September 2012   (final data collection date for primary outcome measure)
Pharmacokinetic profile [ Time Frame: Blood samples will be collected on Days 1, 3, 5 and 7 ] [ Designated as safety issue: No ]
Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations
Same as current
Complete list of historical versions of study NCT01658202 on ClinicalTrials.gov Archive Site
Clinical safety (reported adverse events) [ Time Frame: up to day 9 ] [ Designated as safety issue: Yes ]
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
Same as current
Not Provided
Not Provided
 
Nicotine Patch Bioequivalence Study
Not Provided

The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.

4 single 24hour applications separated by 48hour intervals.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Smokers
  • Drug: V0116 transdermal patch (Test treatment )
  • Drug: Nicotine transdermal patch (Reference Treatment )
  • Sequence 1

    After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.

    Each patch will be applied for 24h.

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

    After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.

    Each patch will be applied for 24h.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01658202
V00116 TD 1 04, 2011-006212-32
Not Provided
Pierre Fabre Medicament
Pierre Fabre Medicament
Not Provided
Not Provided
Pierre Fabre Medicament
December 2012

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