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Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

NCT ID: NCT01084707

Last Updated: 2012-07-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

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A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Detailed Description

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This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 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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Oral Nicotine 24-SA

2 Self-administrations of Experimental Nicotine once every hour

Group Type EXPERIMENTAL

Oral Nicotine

Intervention Type DRUG

Oral Nicotine either self-administered or provided by study personnel within 12 hours

Oral Nicotine 24

2 administrations of Experimental Nicotine by study personnel once every hour

Group Type EXPERIMENTAL

Oral Nicotine

Intervention Type DRUG

Oral Nicotine either self-administered or provided by study personnel within 12 hours

Oral Nicotine 48

2 administrations of Experimental Nicotine by study personnel once every 30 minutes

Group Type EXPERIMENTAL

Oral Nicotine

Intervention Type DRUG

Oral Nicotine either self-administered or provided by study personnel within 12 hours

NiQuitin™ Lozenge 4 mg

1 NiQuitin™ lozenge, administered by study personnel once every hour

Group Type ACTIVE_COMPARATOR

Nicotine Lozenge

Intervention Type DRUG

Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours

Nicorette® Gum 4 mg

1 piece Nicorette® gum, chewed for 30 minutes once every hour

Group Type ACTIVE_COMPARATOR

Nicotine gum

Intervention Type DRUG

Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Interventions

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Oral Nicotine

Oral Nicotine either self-administered or provided by study personnel within 12 hours

Intervention Type DRUG

Nicotine Lozenge

Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours

Intervention Type DRUG

Nicotine gum

Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Intervention Type DRUG

Other Intervention Names

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generic Nicotine NiQuitin™ Nicorette®

Eligibility Criteria

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Inclusion Criteria

* Healthy smokers, smoking at least 20 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.
* Prior regular use of nicotine mouth spray
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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Clinical Pharmacology

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-006279-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1066-A6431117

Identifier Type: -

Identifier Source: org_study_id