Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products

Study Overview
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Brief Summary
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Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.

Detailed Description
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Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.

Official Title
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Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine Medicated Gum
* Drug: 4 mg Nicotine Gum
* Drug: 2 mg Nicotine Gum
* Drug: 4 mg Nicotine Lozenge


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 kilograms per square meter and a total body weight of at least 55.0 kilograms. 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Gum 6<br>6 mg Nicotine medicated gum | Drug: Nicotine Medicated Gum<br>* Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes<br>* Other names: Not marketed;|
| Active Comparator: Nicotine Gum 4<br>4 mg Nicotine Gum | Drug: 4 mg Nicotine Gum<br>* Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes<br>* Other names: Nicorette® Freshfruit gum;|
| Active Comparator: Nicotine Gum 2<br>2 mg Nicotine Gum | Drug: 2 mg Nicotine Gum<br>* Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes<br>* Other names: Nicorette® Freshfruit gum;|
| Active Comparator: Nicotine Lozenge<br>4 mg Nicotine Lozenge | Drug: 4 mg Nicotine Lozenge<br>* Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved<br>* Other names: NiQuitin™ Mint lozenge;|

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) | 12 hours post-dose | 
| Area Under the Curve (AUC)(0-t) | AUC(0-t), which 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). | 12 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. | 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(10 min) | AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes | 10 minutes 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