Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

July 6, 2012 updated by: McNeil AB

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 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. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-222 20
        • McNeil AB Clinical Pharmacology R&D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSC018
Nicotine
Drug: Nicotine
2 mg Single-dose
Other Names:
  • Experimental NRT, Nicorette®
Active Comparator: Nicotine Gum
Nicorette® Gum
Drug: Nicotine
2 mg Single-dose
Other Names:
  • Experimental NRT, Nicorette®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic measurements
Time Frame: Baseline and during 8 hours after product administration

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∞)
Baseline and during 8 hours after product administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tmax
Time Frame: Baseline and during 8 hours after product administration
The time of occurrence of Cmax following product administration
Baseline and during 8 hours after product administration
Lamda z
Time Frame: Baseline and during 8 hours after product administration
The terminal nicotine elimination rate constant (λz)
Baseline and during 8 hours after product administration
Released amount of nicotine
Time Frame: After 30 minutes of chewing
The amount of nicotine released from gums during 30 minutes' chewing
After 30 minutes of chewing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McNeil AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICTDP1073
  • 2008-005520-87 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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