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Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

NCT ID: NCT01227720

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

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-01-31

Brief Summary

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Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Detailed Description

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This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. 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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A NSL2L

Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg

Group Type EXPERIMENTAL

Experimental Nicotine Replacement Therapy (NRT) 2 mg

Intervention Type DRUG

2 mg Single-dose of new NRT product (NSL2L)

B Lozenge

Marketed Nicotine Lozenge 2 mg

Group Type ACTIVE_COMPARATOR

Marketed Nicotine Lozenge

Intervention Type DRUG

2 mg Single-dose of marketed lozenge

C NSL4M

Experimental NRT (M) 4 mg

Group Type EXPERIMENTAL

Experimental Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

4 mg Single-dose of new NRT product

D Lozenge

Marketed Nicotine Lozenge 4 mg

Group Type ACTIVE_COMPARATOR

Marketed Nicotine Lozenge

Intervention Type DRUG

4 mg Single-dose of marketed lozenge

E NSL4L

Experimental NRT (L) 4 mg

Group Type EXPERIMENTAL

Experimental Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

4 mg Single-dose of new NRT product

F NSL4H

Experimental NRT (H) 4 mg

Group Type EXPERIMENTAL

Experimental Nicotine Replacement Therapy (NRT)

Intervention Type DRUG

4 mg Single-dose of new NRT product

Interventions

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Experimental Nicotine Replacement Therapy (NRT) 2 mg

2 mg Single-dose of new NRT product (NSL2L)

Intervention Type DRUG

Experimental Nicotine Replacement Therapy (NRT)

4 mg Single-dose of new NRT product

Intervention Type DRUG

Marketed Nicotine Lozenge

2 mg Single-dose of marketed lozenge

Intervention Type DRUG

Marketed Nicotine Lozenge

4 mg Single-dose of marketed lozenge

Intervention Type DRUG

Other Intervention Names

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Not yet marketed Not yet marketed NiQuitin™ lozenge NiQuitin™ lozenge

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects, smoking at least 10 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.
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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Lund University Hospital Clinical Trial Unit

Lund, , Sweden

Site Status

McNeil AB Clinical Pharmacology R&D

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NICTDP1076

Identifier Type: -

Identifier Source: org_study_id