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Nicotine Patch Bioequivalence Study

NCT01658202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-12-11

No results posted yet for this study

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.

Conditions

  • Healthy Smokers

Interventions

DRUG

V0116 transdermal patch (Test treatment )

DRUG

Nicotine transdermal patch (Reference Treatment )

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658202 on ClinicalTrials.gov