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

Study Overview
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Brief Summary
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Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Detailed Description
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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.

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

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: 6 mg Experimental nicotine gum
* Drug: 4 mg Nicotine Gum/
* Drug: 2 mg Nicotine Gum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | 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) | 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-∞) | AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity. | 8 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Nicotine pharmacokinetics