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Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Nicotine

Nicorette® (Nicotine Gum)

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring Smoking Cessation, Nicotine pharmacokinetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy smokers, 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.

Sites / Locations

Berzelius Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

NRT-2

GUM-2

NRT-4

GUM-4

Arm Description

2 mg single-dose of a new NRT product

2 mg single-dose of a marketed nicotine gum

4 mg single-dose of a new NRT product

4 mg single-dose of marketed nicotine gum

Outcomes

Primary Outcome Measures

Pharmacokinetic measurements

Pharmacokinetic measurements including: the maximum observed nicotine concentration in plasma (Cmax) the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) the area under the plasma concentration-vs.-time curve until infinity (AUCinf)

Secondary Outcome Measures

Tmax

The time of occurrence of Cmax (tmax) following product administration

λz

The terminal nicotine elimination rate constant (λz)

Residual Nicotine

The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.

Dissolution Time

Actual time required for oral dissolution of new NRT products following product administration

Full Information

NCT ID

NCT01113424

First Posted

April 28, 2010

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01113424

Brief Title

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Official Title

Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - A Study in Healthy Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McNeil AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Detailed Description

This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

Keywords

Smoking Cessation, Nicotine pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NRT-2

Arm Type

Experimental

Arm Description

2 mg single-dose of a new NRT product

Arm Title

GUM-2

Arm Type

Active Comparator

Arm Description

2 mg single-dose of a marketed nicotine gum

Arm Title

NRT-4

Arm Type

Experimental

Arm Description

4 mg single-dose of a new NRT product

Arm Title

GUM-4

Arm Type

Active Comparator

Arm Description

4 mg single-dose of marketed nicotine gum

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Not yet marketed

Intervention Description

Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg

Intervention Type

Drug

Intervention Name(s)

Nicorette® (Nicotine Gum)

Other Intervention Name(s)

Nicorette®

Intervention Description

Single-dose of marketed nicotine gum 2 mg or 4 mg

Primary Outcome Measure Information:

Title

Pharmacokinetic measurements

Description

Time Frame

Baseline and during 10 hours after product administration

Secondary Outcome Measure Information:

Title

Tmax

Description

The time of occurrence of Cmax (tmax) following product administration

Time Frame

during 10 hours after start of product administration

Title

λz

Description

The terminal nicotine elimination rate constant (λz)

Time Frame

during 10 hours after start of product administration

Title

Residual Nicotine

Description

The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing.

Time Frame

After 30 minutes of chewing

Title

Dissolution Time

Description

Actual time required for oral dissolution of new NRT products following product administration

Time Frame

From product administration until completely dissolved

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy smokers, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Kruse, PhD

Organizational Affiliation

McNeil AB

Official's Role

Study Director

Facility Information:

Facility Name

Berzelius Clinical Research Center

City

Linköping

ZIP/Postal Code

SE-582 25

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

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