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Completed

NCT Number: NCT01228617

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

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

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Key information

Conditions

Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Unit, Clinical Research and Trial Centre

Lund, SE-221 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicotine

Drug

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

Nicotine gum

Drug

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®

Primary outcomes

  1. Maximum Concentration

    Time frame: Baseline to 10 hours post-dose

    The maximum observed nicotine concentration in plasma (Cmax)

  2. 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∞)

Secondary outcomes

  1. Time to Maximum Concentration

    Time frame: 10 hours post-dose

    Time to Maximum Concentration (Tmax)

  2. Residual Nicotine

    Time frame: 30 minutes

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

  3. Dissolution Time

    Time frame: 10 hours post-dose

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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 26, 2010
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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