Nicotine Lozenge Bioequivalence Study

Study Overview
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Brief Summary
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To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.

Official Title
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A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

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: Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking. Body Mass Index within the range 19-27 kilograms/meters^2 Exclusion Criteria: Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

Ages Eligible for Study
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Minimum Age: 19 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: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test nicotine lozenge (2 mg)<br>2 mg test nicotine lozenge to be chewed. | Drug: Nicotine (2 mg)<br>* 2 mg nicotine lozenge in two formulations<br>|
| Experimental: Test nicotine lozenge (4 mg)<br>4 mg test nicotine lozenge to be chewed. | Drug: Nicotine (4 mg)<br>* 4 mg nicotine lozenge in two formulations<br>|
| Active Comparator: Reference nicotine lozenge (2 mg)<br>2 mg reference nicotine lozenge to be chewed. | Drug: Nicotine (2 mg)<br>* 2 mg nicotine lozenge in two formulations<br>|
| Active Comparator: Reference nicotine lozenge (4 mg)<br>4 mg reference nicotine lozenge to be chewed. | Drug: Nicotine (4 mg)<br>* 4 mg nicotine lozenge 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 Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] | AUC(0-t) was evaluated using the trapezoid rule. | Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours | 
| Maximum Observed Plasma Concentration [Cmaximum (Max)] | Cmax was depicted from plasma concentration of nicotine. | Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC [0-infinity (Inf)] | AUC (0-inf) was evaluated using the trapezoid rule. | Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours | 
| Time to Reach Maximum Plasma Nicotine Concentration (Tmax) | Tmax was time at which Cmax of nicotine was reached. | Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours | 
| Apparent Elimination Half-life of Nicotine T(1/2) | T(1/2) was calculated using plasma time-concentration values. | Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours | 
| Elimination Rate Constant for Plasma Nicotine: K (el) | Kel was calculated with the help of plasma time concentration values. | Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours | 

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