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Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

NCT ID: NCT01084603

Last Updated: 2012-07-13

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

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-06-30

Brief Summary

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A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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 1

One oral administration of 1 mg nicotine

Group Type EXPERIMENTAL

Oral Nicotine

Intervention Type DRUG

A new l mg oral nicotine product

Oral Nicotine 2

Two oral administrations of 1 mg nicotine

Group Type EXPERIMENTAL

Oral Nicotine

Intervention Type DRUG

A new l mg oral nicotine product

Oral Nicotine 4

Four oral administrations of 1 mg nicotine

Group Type EXPERIMENTAL

Oral Nicotine

Intervention Type DRUG

A new l mg oral nicotine product

NiQuitinTM Nicotine Lozenge 4 mg

One 4 mg marketed nicotine lozenge

Group Type ACTIVE_COMPARATOR

NiQuitinTM Nicotine Lozenge

Intervention Type DRUG

A marketed 4 mg Nicotine lozenge

Nicorette® Gum 4 mg

One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes

Group Type ACTIVE_COMPARATOR

Nicorette® Nicotine Gum

Intervention Type DRUG

A marketed 4 mg Nicotine Gum

Interventions

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Oral Nicotine

A new l mg oral nicotine product

Intervention Type DRUG

NiQuitinTM Nicotine Lozenge

A marketed 4 mg Nicotine lozenge

Intervention Type DRUG

Nicorette® Nicotine Gum

A marketed 4 mg Nicotine Gum

Intervention Type DRUG

Other Intervention Names

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Experimental nicotine 1 mg NiQuitinTM lozenge Nicorette® gum

Eligibility Criteria

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Inclusion Criteria

* Healthy smokers, smoking at least 15 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 months 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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Clinical Pharmacology

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-006280-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1065/A6431116

Identifier Type: -

Identifier Source: org_study_id