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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 31, 2012
Last Updated Date	December 10, 2012
Start Date ^ICMJE	August 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 1, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01658202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 1, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Nicotine Patch Bioequivalence Study
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy Smokers
Intervention ^ICMJE	Drug: V0116 transdermal patch (Test treatment ) Drug: Nicotine transdermal patch (Reference Treatment )
Study Arm (s)	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 )
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
Enrollment ^ICMJE	28
Completion Date	September 2012
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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01658202
Other Study ID Numbers ^ICMJE	V00116 TD 1 04, 2011-006212-32
Has Data Monitoring Committee	Not Provided
Responsible Party	Pierre Fabre Medicament
Study Sponsor ^ICMJE	Pierre Fabre Medicament
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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