Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum

Study Overview
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Brief Summary
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This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.

Detailed Description
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The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur.

Official Title
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Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum. A Study in Healthy Smokers.

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine
* Drug: Nicotine Gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and body mass index (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: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UNG-GC-2<br>2 mg experimental NRT product | Drug: Nicotine<br>* Single-dose of new NRT product<br>* Other names: Nicotine NRT / not yet marketed;|
| Experimental: UNG-GC-4<br>4 mg experimental NRT product | Drug: Nicotine<br>* Single-dose of new NRT product<br>* Other names: Nicotine NRT / not yet marketed;|
| Active Comparator: Nicorette® Gum-2<br>2 mg Nicorette® Gum | Drug: Nicotine Gum<br>* Single-dose of marketed nicotine gum<br>* Other names: Nicorette® Gum;|
| Active Comparator: Nicorette® Gum-4<br>4 mg Nicorette® Gum | Drug: Nicotine Gum<br>* Single-dose of marketed nicotine gum<br>* Other names: Nicorette® Gum;|

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 (AUC∞) | Baseline and during 10 hours after product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax | The time of occurrence of Cmax following product administration | Baseline and during 10 hours after product administration | 
| Lamda z | The terminal nicotine elimination rate constant (λz) | Baseline and during 10 hours after product administration | 
| Released amount of nicotine | The amount of nicotine released from gums during 30 minutes' chewing. | After 30 minutes of chewing | 

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