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Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Nicotine

Nicotine Gum

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

McNeil AB Clinical Pharmacology R&D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

UNG-GC-2

UNG-GC-4

Nicorette® Gum-2

Nicorette® Gum-4

Arm Description

2 mg experimental NRT product

4 mg experimental NRT product

2 mg Nicorette® Gum

4 mg Nicorette® 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 (AUC∞)

Secondary Outcome Measures

tmax

The time of occurrence of Cmax following product administration

Lamda z

The terminal nicotine elimination rate constant (λz)

Released amount of nicotine

The amount of nicotine released from gums during 30 minutes' chewing.

Full Information

NCT ID

NCT01152749

First Posted

June 28, 2010

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01152749

Brief Title

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Official Title

Bioequivalence Between an Oral Nicotine Replacement Product 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

December 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

May 2010 (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

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

Detailed Description

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.

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UNG-GC-2

Arm Type

Experimental

Arm Description

2 mg experimental NRT product

Arm Title

UNG-GC-4

Arm Type

Experimental

Arm Description

4 mg experimental NRT product

Arm Title

Nicorette® Gum-2

Arm Type

Active Comparator

Arm Description

2 mg Nicorette® Gum

Arm Title

Nicorette® Gum-4

Arm Type

Active Comparator

Arm Description

4 mg Nicorette® Gum

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Nicotine NRT / not yet marketed

Intervention Description

Single-dose of new NRT product

Intervention Type

Drug

Intervention Name(s)

Nicotine Gum

Other Intervention Name(s)

Nicorette® Gum

Intervention Description

Single-dose of marketed nicotine gum

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 following product administration

Time Frame

Baseline and during 10 hours after product administration

Title

Lamda z

Description

The terminal nicotine elimination rate constant (λz)

Time Frame

Baseline and during 10 hours after product administration

Title

Released amount of nicotine

Description

The amount of nicotine released from gums during 30 minutes' chewing.

Time Frame

After 30 minutes of chewing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

McNeil AB Clinical Pharmacology R&D

City

Lund

ZIP/Postal Code

SE-222 20

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

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