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Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

NCT ID: NCT01113424

Last Updated: 2012-07-10

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

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Detailed Description

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This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Conditions

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Tobacco Dependence

Keywords

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Smoking Cessation Nicotine pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NRT-2

2 mg single-dose of a new NRT product

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg

GUM-2

2 mg single-dose of a marketed nicotine gum

Group Type ACTIVE_COMPARATOR

Nicorette® (Nicotine Gum)

Intervention Type DRUG

Single-dose of marketed nicotine gum 2 mg or 4 mg

NRT-4

4 mg single-dose of a new NRT product

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg

GUM-4

4 mg single-dose of marketed nicotine gum

Group Type ACTIVE_COMPARATOR

Nicorette® (Nicotine Gum)

Intervention Type DRUG

Single-dose of marketed nicotine gum 2 mg or 4 mg

Interventions

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Nicotine

Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg

Intervention Type DRUG

Nicorette® (Nicotine Gum)

Single-dose of marketed nicotine gum 2 mg or 4 mg

Intervention Type DRUG

Other Intervention Names

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Not yet marketed Nicorette®

Eligibility Criteria

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Inclusion Criteria

* Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

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Berzelius Clinical Research Center

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-003358-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1071

Identifier Type: -

Identifier Source: org_study_id