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Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

NCT ID: NCT01152749

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

Brief Summary

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This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Detailed Description

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The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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UNG-GC-2

2 mg experimental NRT product

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Single-dose of new NRT product

UNG-GC-4

4 mg experimental NRT product

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Single-dose of new NRT product

Nicorette® Gum-2

2 mg Nicorette® Gum

Group Type ACTIVE_COMPARATOR

Nicotine Gum

Intervention Type DRUG

Single-dose of marketed nicotine gum

Nicorette® Gum-4

4 mg Nicorette® Gum

Group Type ACTIVE_COMPARATOR

Nicotine Gum

Intervention Type DRUG

Single-dose of marketed nicotine gum

Interventions

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Nicotine

Single-dose of new NRT product

Intervention Type DRUG

Nicotine Gum

Single-dose of marketed nicotine gum

Intervention Type DRUG

Other Intervention Names

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Nicotine NRT / not yet marketed Nicorette® Gum

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (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

19 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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2009-010633-44

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1075

Identifier Type: -

Identifier Source: org_study_id