Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

Study Overview
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Brief Summary
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Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Detailed Description
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This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Official Title
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Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg
* Drug: Experimental Nicotine Replacement Therapy (NRT)
* Drug: Marketed Nicotine Lozenge
* Drug: Marketed Nicotine Lozenge


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 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A NSL2L<br>Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg | Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg<br>* 2 mg Single-dose of new NRT product (NSL2L)<br>* Other names: Not yet marketed;|
| Active Comparator: B Lozenge<br>Marketed Nicotine Lozenge 2 mg | Drug: Marketed Nicotine Lozenge<br>* 2 mg Single-dose of marketed lozenge<br>* Other names: NiQuitin™ lozenge;|
| Experimental: C NSL4M<br>Experimental NRT (M) 4 mg | Drug: Experimental Nicotine Replacement Therapy (NRT)<br>* 4 mg Single-dose of new NRT product<br>* Other names: Not yet marketed;|
| Active Comparator: D Lozenge<br>Marketed Nicotine Lozenge 4 mg | Drug: Marketed Nicotine Lozenge<br>* 4 mg Single-dose of marketed lozenge<br>* Other names: NiQuitin™ lozenge;|
| Experimental: E NSL4L<br>Experimental NRT (L) 4 mg | Drug: Experimental Nicotine Replacement Therapy (NRT)<br>* 4 mg Single-dose of new NRT product<br>* Other names: Not yet marketed;|
| Experimental: F NSL4H<br>Experimental NRT (H) 4 mg | Drug: Experimental Nicotine Replacement Therapy (NRT)<br>* 4 mg Single-dose of new NRT product<br>* Other names: Not yet marketed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration | The maximum observed nicotine concentration in plasma (Cmax) | during 12 hours after product administration | 
| Area under the Curve | 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∞) | after 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Maximum Concentration | The time of occurrence of maximum concentration (Tmax) | during 12 hours after start of product administration | 
| Terminal Elimination Rate Constant | The terminal nicotine elimination rate constant (λz) | during 12 hours after start of product administration | 
| Oral Dissolution Time | Actual time required for oral dissolution | from 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