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Completed

NCT Number: NCT01084603

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

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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 Pharmacology

Lund, 222 20, Sweden

About this study

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

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 15 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 months preceding the first dose of study medication.

Treatment and study plan

Oral Nicotine

Drug

A new l mg oral nicotine product

Other names: Experimental nicotine 1 mg

NiQuitinTM Nicotine Lozenge

Drug

A marketed 4 mg Nicotine lozenge

Other names: NiQuitinTM lozenge

Nicorette® Nicotine Gum

Drug

A marketed 4 mg Nicotine Gum

Other names: Nicorette® gum

Primary outcomes

  1. Maximum Plasma Concentration

    Time frame: During 12 hours after start of administration

    Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

  2. Bioavailability

    Time frame: 12 hours

    A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).

Secondary outcomes

  1. Nicotine Plasma Concentration

    Time frame: During 10 minutes after start of administration

    Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)

  2. Time of Maximum Concentration

    Time frame: During 12 hours after start of administration

    The time at which maximum concentration is reached (Tmax)

  3. Terminal Elimination Rate Constant

    Time frame: During 12 hours after start of administration

    The terminal nicotine elimination rate constant (Lamda z)

  4. Released Nicotine

    Time frame: After 30 minutes' chewing

    The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing

Sponsors and collaborators

Lead sponsor

McNeil AB

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2010
Registry last updated
Jul 13, 2012

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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