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OpenTrials
Completed

NCT Number: NCT01658202

Nicotine Patch Bioequivalence Study

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.

Completed

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Key information

Conditions

Healthy Smokers Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V0116 transdermal patch (Test treatment )

Drug

Nicotine transdermal patch (Reference treatment )

Drug

Primary outcomes

  1. Pharmacokinetic profile

    Time frame: Blood samples will be collected on Days 1, 3, 5 and 7

    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

Secondary outcomes

  1. Clinical safety (reported adverse events)

    Time frame: up to day 9

    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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2012
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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