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Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

NCT ID: NCT01234896

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Detailed Description

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Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will 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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nicotine Gum 6

6 mg Nicotine medicated gum

Group Type EXPERIMENTAL

Nicotine Medicated Gum

Intervention Type DRUG

Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes

Nicotine Gum 4

4 mg Nicotine Gum

Group Type ACTIVE_COMPARATOR

4 mg Nicotine Gum

Intervention Type DRUG

Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes

Nicotine Gum 2

2 mg Nicotine Gum

Group Type ACTIVE_COMPARATOR

2 mg Nicotine Gum

Intervention Type DRUG

Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes

Nicotine Lozenge

4 mg Nicotine Lozenge

Group Type ACTIVE_COMPARATOR

4 mg Nicotine Lozenge

Intervention Type DRUG

Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved

Interventions

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Nicotine Medicated Gum

Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes

Intervention Type DRUG

4 mg Nicotine Gum

Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes

Intervention Type DRUG

2 mg Nicotine Gum

Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes

Intervention Type DRUG

4 mg Nicotine Lozenge

Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved

Intervention Type DRUG

Other Intervention Names

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Not marketed Nicorette® Freshfruit gum Nicorette® Freshfruit gum NiQuitin™ Mint lozenge

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 kilograms per square meter and a total body weight of at least 55.0 kilograms.
* 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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2010-021087-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1080

Identifier Type: -

Identifier Source: org_study_id