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Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

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

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

Clinical Trial Unit, Clinical Research and Trial Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Arm Label

A1 Short, no buffer

A2 Short, low buffer

A3 Short, high buffer

B1 Long, no buffer

B2 Long, low buffer

B3 Long, high buffer

R = Nicotine Gum

Arm Description

Nicotine / not yet marketed

Nicorette® Gum

Outcomes

Primary Outcome Measures

Maximum Concentration

The maximum observed nicotine concentration in plasma (Cmax)

Area under the Curve

The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

Secondary Outcome Measures

Time to Maximum Concentration

Time to Maximum Concentration (Tmax)

Residual Nicotine

The amount of residual nicotine in the product after being chewed.

Dissolution Time

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

Full Information

NCT ID

NCT01228617

First Posted

October 25, 2010

Last Updated

October 4, 2011

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

1. Study Identification

Unique Protocol Identification Number

NCT01228617

Brief Title

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Official Title

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.

Detailed Description

This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A1 Short, no buffer

Arm Type

Experimental

Arm Description

Nicotine / not yet marketed

Arm Title

A2 Short, low buffer

Arm Type

Experimental

Arm Description

Nicotine / not yet marketed

Arm Title

A3 Short, high buffer

Arm Type

Experimental

Arm Description

Nicotine / not yet marketed

Arm Title

B1 Long, no buffer

Arm Type

Experimental

Arm Description

Nicotine / not yet marketed

Arm Title

B2 Long, low buffer

Arm Type

Experimental

Arm Description

Nicotine / not yet marketed

Arm Title

B3 Long, high buffer

Arm Type

Experimental

Arm Description

Nicotine / not yet marketed

Arm Title

R = Nicotine Gum

Arm Type

Active Comparator

Arm Description

Nicorette® Gum

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Not yet marketed

Intervention Description

Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day

Intervention Type

Drug

Intervention Name(s)

Nicotine Gum

Other Intervention Name(s)

Nicorette®

Intervention Description

Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.

Primary Outcome Measure Information:

Title

Maximum Concentration

Description

The maximum observed nicotine concentration in plasma (Cmax)

Time Frame

Baseline to 10 hours post-dose

Title

Area under the Curve

Description

The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)

Time Frame

10 hours post-dose

Secondary Outcome Measure Information:

Title

Time to Maximum Concentration

Description

Time to Maximum Concentration (Tmax)

Time Frame

10 hours post-dose

Title

Residual Nicotine

Description

The amount of residual nicotine in the product after being chewed.

Time Frame

30 minutes

Title

Dissolution Time

Description

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

Time Frame

10 hours post-dose

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

Clinical Trial Unit, Clinical Research and Trial Centre

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

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