Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Study Overview
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Brief Summary
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Bioequivalence between oral nicotine replacement products and Nicorette® gum.

Detailed Description
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This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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.

Official Title
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Bioequivalence Between Oral Nicotine Replacement Products and Nicorette® Gum - A Study in Healthy Smokers

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine
* Drug: Nicorette® (Nicotine Gum)


Participation Criteria
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Eligibility Criteria
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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.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NRT-2<br>2 mg single-dose of a new NRT product | Drug: Nicotine<br>* Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg<br>* Other names: Not yet marketed;|
| Active Comparator: GUM-2<br>2 mg single-dose of a marketed nicotine gum | Drug: Nicorette® (Nicotine Gum)<br>* Single-dose of marketed nicotine gum 2 mg or 4 mg<br>* Other names: Nicorette®;|
| Experimental: NRT-4<br>4 mg single-dose of a new NRT product | Drug: Nicotine<br>* Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg<br>* Other names: Not yet marketed;|
| Active Comparator: GUM-4<br>4 mg single-dose of marketed nicotine gum | Drug: Nicorette® (Nicotine Gum)<br>* Single-dose of marketed nicotine gum 2 mg or 4 mg<br>* Other names: Nicorette®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic measurements | Pharmacokinetic measurements including: the maximum observed nicotine concentration in plasma (Cmax) the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) the area under the plasma concentration-vs.-time curve until infinity (AUCinf) | Baseline and during 10 hours after product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | The time of occurrence of Cmax (tmax) following product administration | during 10 hours after start of product administration | 
| λz | The terminal nicotine elimination rate constant (λz) | during 10 hours after start of product administration | 
| Residual Nicotine | The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing. | After 30 minutes of chewing | 
| Dissolution Time | Actual time required for oral dissolution of new NRT products following product administration | From product administration until completely dissolved | 

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