Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

March 6, 2014 updated by: GlaxoSmithKline

A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design

The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

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

    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 6AD
        • Celerion - BELFAST

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI within the range of 19 to 30 kilograms/meters^2
  • Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Exclusion Criteria:

  • Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
  • Treatment with known hepatic enzyme altering agents

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test nicotine gum (2 mg)
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
2 mg nicotine gum in two formulations
Experimental: Test nicotine gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
4 mg nicotine gum in two formulations
Active Comparator: Reference nicotine gum (2 mg)
A single dose of reference nicotine gum (2 mg) to be chewed.
2 mg nicotine gum in two formulations
Active Comparator: Reference nicotine gum (4 mg)
A single dose of reference nicotine gum (4 mg) to be chewed.
4 mg nicotine gum in two formulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
Cmax for 2 mg test was compared with 2 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose
Cmax of Nicotine 4 mg Test and Reference Product
Time Frame: Blood samples to be collected from baseline to 12 hours post-dose
Cmax for 4 mg test was compared with 4 mg reference gum
Blood samples to be collected from baseline to 12 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose
Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time Frame: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Blood samples to be collected from baseline to 12 hours post dose

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 6, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

January 1, 2014

More Information

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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