A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

NCT ID: NCT01702519

Last Updated: 2015-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-03-31

Brief Summary

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Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.

Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Reference

nicotine transdermal patch with the existing polyisobutylene adhesive

Group Type ACTIVE_COMPARATOR

nicotine

Intervention Type DRUG

nicotine transdermal patch

Treatement

nicotine transdermal patch with the alternate polyisobutylene adhesive

Group Type ACTIVE_COMPARATOR

nicotine

Intervention Type DRUG

nicotine transdermal patch

Interventions

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nicotine

nicotine transdermal patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 19-27 kg/m2
* smokes \>10 cigarettes per day for preceeding 6 months

Exclusion Criteria

* inability to stop smoking during study
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Celerion NEBRASKA

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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RH01418

Identifier Type: -

Identifier Source: org_study_id

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