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Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Nicotine Medicated Gum

4 mg Nicotine Gum

2 mg Nicotine Gum

4 mg Nicotine Lozenge

About this trial

This is an interventional basic science 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 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.

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

Nicotine Gum 6

Nicotine Gum 4

Nicotine Gum 2

Nicotine Lozenge

Arm Description

6 mg Nicotine medicated gum

4 mg Nicotine Gum

2 mg Nicotine Gum

4 mg Nicotine Lozenge

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

Area Under the Curve (AUC)(0-t)

AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).

AUC (0-∞)

AUC (0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Secondary Outcome Measures

AUC(10 min)

AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes

Full Information

NCT ID

NCT01234896

First Posted

November 3, 2010

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01234896

Brief Title

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Official Title

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

December 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

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

Detailed Description

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.

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

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotine Gum 6

Arm Type

Experimental

Arm Description

6 mg Nicotine medicated gum

Arm Title

Nicotine Gum 4

Arm Type

Active Comparator

Arm Description

4 mg Nicotine Gum

Arm Title

Nicotine Gum 2

Arm Type

Active Comparator

Arm Description

2 mg Nicotine Gum

Arm Title

Nicotine Lozenge

Arm Type

Active Comparator

Arm Description

4 mg Nicotine Lozenge

Intervention Type

Drug

Intervention Name(s)

Nicotine Medicated Gum

Other Intervention Name(s)

Not marketed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

4 mg Nicotine Gum

Other Intervention Name(s)

Nicorette® Freshfruit gum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

2 mg Nicotine Gum

Other Intervention Name(s)

Nicorette® Freshfruit gum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

4 mg Nicotine Lozenge

Other Intervention Name(s)

NiQuitin™ Mint lozenge

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

Time Frame

12 hours post-dose

Title

Area Under the Curve (AUC)(0-t)

Description

Time Frame

12 hours post-dose

Title

AUC (0-∞)

Description

AUC (0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Time Frame

12 hours post-dose

Secondary Outcome Measure Information:

Title

AUC(10 min)

Description

AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes

Time Frame

10 minutes post-dose

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 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.

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

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Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

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