Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

Study Overview
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Brief Summary
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The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Detailed Description
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The trial has a single-dose, randomized, crossover design and includes 84 subjects. 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. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Official Title
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Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab. A Study in Healthy Smokers

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Code STD
* Drug: Code STE
* Drug: Nicorette Microtab


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: 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: Code STD<br>An experimental 2 mg nicotine product coded STD | Drug: Code STD<br>* 2 mg Single-dose of experimental nicotine product coded STD<br>* Other names: Not marketed;|
| Experimental: Code STE<br>An experimental 2 mg nicotine product coded STE | Drug: Code STE<br>* 2 mg Single-dose of experimental nicotine product coded STE<br>* Other names: Not marketed;|
| Active Comparator: Nicorette Microtab<br>A comparative 2 mg marketed nicotine product called Nicorette Microtab | Drug: Nicorette Microtab<br>* A comparative 2 mg Single-dose of marketed tablet<br>* Other names: Nicorette® Microtab;|

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 after a dose is administered, measured in nanograms/milliliter (ng/mL) | During 10 hours post-dose | 
| Area Under the Curve [AUC(0-t)] | Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses 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 10 hours post-dose | 
| AUC(0-∞) | AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞). | 10 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Dissolution Time | Product Dissolution Time is the time from administration until the investigational products were completely dissolved. | During 10 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