Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

October 4, 2011 updated by: Johnson & Johnson Consumer and Personal Products Worldwide

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

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-221 85
        • Clinical Trial Unit, Clinical Research and Trial Centre

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 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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1 Short, no buffer
Nicotine / not yet marketed
Drug: Nicotine
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
Other Names:
  • Not yet marketed
Experimental: A2 Short, low buffer
Nicotine / not yet marketed
Drug: Nicotine
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
Other Names:
  • Not yet marketed
Experimental: A3 Short, high buffer
Nicotine / not yet marketed
Drug: Nicotine
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
Other Names:
  • Not yet marketed
Experimental: B1 Long, no buffer
Nicotine / not yet marketed
Drug: Nicotine
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
Other Names:
  • Not yet marketed
Experimental: B2 Long, low buffer
Nicotine / not yet marketed
Drug: Nicotine
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
Other Names:
  • Not yet marketed
Experimental: B3 Long, high buffer
Nicotine / not yet marketed
Drug: Nicotine
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
Other Names:
  • Not yet marketed
Active Comparator: R = Nicotine Gum
Nicorette® Gum
Drug: Nicotine Gum
Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
Other Names:
  • Nicorette®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Concentration
Time Frame: Baseline to 10 hours post-dose
The maximum observed nicotine concentration in plasma (Cmax)
Baseline to 10 hours post-dose
Area under the Curve
Time Frame: 10 hours post-dose
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∞)
10 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Maximum Concentration
Time Frame: 10 hours post-dose
Time to Maximum Concentration (Tmax)
10 hours post-dose
Residual Nicotine
Time Frame: 30 minutes
The amount of residual nicotine in the product after being chewed.
30 minutes
Dissolution Time
Time Frame: 10 hours post-dose
Actual time required for oral dissolution of new NRT products following product administration
10 hours post-dose

Collaborators and Investigators

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

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

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

September 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6431114-NICTDP1063

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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