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Nicotine Patch Bioequivalence Study

NCT ID: NCT01658202

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Healthy Smokers

Keywords

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Smoking cessation Nicotine Tobacco Use Disorder Central Nervous System Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

V0116 transdermal patch (Test treatment )

Intervention Type DRUG

Nicotine transdermal patch (Reference Treatment )

Intervention Type DRUG

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.

Group Type OTHER

V0116 transdermal patch (Test treatment )

Intervention Type DRUG

Nicotine transdermal patch (Reference Treatment )

Intervention Type DRUG

Interventions

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V0116 transdermal patch (Test treatment )

Intervention Type DRUG

Nicotine transdermal patch (Reference Treatment )

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2011-006212-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V00116 TD 1 04

Identifier Type: -

Identifier Source: org_study_id