Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Study Overview
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Brief Summary
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The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Official Title
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A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine (2 mg)
* Drug: Nicotine (4 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI within the range of 19 to 30 kilograms/meters^2 Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up Exclusion Criteria: Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids Treatment with known hepatic enzyme altering agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Test nicotine gum (2 mg)<br>A single dose of Nicotine Mint Gum (2 mg) to be chewed. | Drug: Nicotine (2 mg)<br>* 2 mg nicotine gum in two formulations<br>|
| Experimental: Test nicotine gum (4 mg)<br>A single dose of Nicotine Mint Gum (4 mg) to be chewed. | Drug: Nicotine (4 mg)<br>* 4 mg nicotine gum in two formulations<br>|
| Active Comparator: Reference nicotine gum (2 mg)<br>A single dose of reference nicotine gum (2 mg) to be chewed. | Drug: Nicotine (2 mg)<br>* 2 mg nicotine gum in two formulations<br>|
| Active Comparator: Reference nicotine gum (4 mg)<br>A single dose of reference nicotine gum (4 mg) to be chewed. | Drug: Nicotine (4 mg)<br>* 4 mg nicotine gum in two formulations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product | AUC(0-t) for 2 mg test was compared with 2 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 
| AUC(0-t) of Nicotine 4 mg Test and Reference Product | AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 
| Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product | Cmax for 2 mg test was compared with 2 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 
| Cmax of Nicotine 4 mg Test and Reference Product | Cmax for 4 mg test was compared with 4 mg reference gum | Blood samples to be collected from baseline to 12 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products | Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 
| Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products | T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 
| Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products | Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 
| Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products | AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum | Blood samples to be collected from baseline to 12 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine gum, nicotine, nicotine replacement therapy