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Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

NCT ID: NCT01321931

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

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Detailed Description

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Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each 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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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NRT 60

A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

6 mg experimental Nicotine Replacement Therapy (NRT)

NFG 60

A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

4 mg marketed Nicotine Fruit Gum (NFG)

NRT 90

A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

6 mg experimental Nicotine Replacement Therapy (NRT)

NFG 90

A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

4 mg marketed Nicotine Fruit Gum (NFG)

NIQ 60

A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

4 mg marketed nicotine mint lozenge (NIQ)

Interventions

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Nicotine

6 mg experimental Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

Nicotine

4 mg marketed Nicotine Fruit Gum (NFG)

Intervention Type DRUG

Nicotine

4 mg marketed nicotine mint lozenge (NIQ)

Intervention Type DRUG

Other Intervention Names

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Not yet marketed Nicorette® Freshfruit Gum NiQuitinTM Mint lozenge

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
* 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.
* Willing and able to comply with all scheduled visits and study procedures

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.
* Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.
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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2010-023026-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NICTDP1081

Identifier Type: -

Identifier Source: org_study_id