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Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

NCT ID: NCT01234792

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-06-30

Brief Summary

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Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Detailed Description

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The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NIC-6

6 mg Experimental nicotine gum

Group Type EXPERIMENTAL

6 mg Experimental nicotine gum

Intervention Type DRUG

A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits

NIC-4

4 mg Nicotine Gum

Group Type ACTIVE_COMPARATOR

4 mg Nicotine Gum/

Intervention Type DRUG

A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits

NIC-2

2 mg Nicotine Gum

Group Type ACTIVE_COMPARATOR

2 mg Nicotine Gum

Intervention Type DRUG

A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits

Interventions

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6 mg Experimental nicotine gum

A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits

Intervention Type DRUG

4 mg Nicotine Gum/

A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits

Intervention Type DRUG

2 mg Nicotine Gum

A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits

Intervention Type DRUG

Other Intervention Names

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Not marketed Nicorette® Gum Nicorette® Gum

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
* 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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McNeil AB Clinical Pharmacology R&D

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-000596-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1070

Identifier Type: -

Identifier Source: org_study_id