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

July 6, 2012 updated by: McNeil AB

Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - A Study in Healthy Smokers

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Study Type

Interventional

Enrollment (Actual)

24

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 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
  • 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIC-6
6 mg Experimental nicotine gum
Drug: 6 mg Experimental nicotine gum
A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
Other Names:
  • Not marketed
Active Comparator: NIC-4
4 mg Nicotine Gum
Drug: 4 mg Nicotine Gum/
A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
Other Names:
  • Nicorette® Gum
Active Comparator: NIC-2
2 mg Nicotine Gum
Drug: 2 mg Nicotine Gum
A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits
Other Names:
  • Nicorette® Gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: During 8 hours post-dose
Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)
During 8 hours post-dose
Area Under the Curve (AUC)(0-t)
Time Frame: During 8 hours post-dose
AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).
During 8 hours post-dose
AUC(0-∞)
Time Frame: 8 hours post-dose
AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
8 hours post-dose

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

May 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 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

  • NICTDP1070
  • 2008-000596-15 (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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