Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test nicotine gum (2 mg)

A single dose of Nicotine Mint Gum (2 mg) to be chewed.

Group Type EXPERIMENTAL

Nicotine (2 mg)

Intervention Type DRUG

2 mg nicotine gum in two formulations

Test nicotine gum (4 mg)

A single dose of Nicotine Mint Gum (4 mg) to be chewed.

Group Type EXPERIMENTAL

Nicotine (4 mg)

Intervention Type DRUG

4 mg nicotine gum in two formulations

Reference nicotine gum (2 mg)

A single dose of reference nicotine gum (2 mg) to be chewed.

Group Type ACTIVE_COMPARATOR

Nicotine (2 mg)

Intervention Type DRUG

2 mg nicotine gum in two formulations

Reference nicotine gum (4 mg)

A single dose of reference nicotine gum (4 mg) to be chewed.

Group Type ACTIVE_COMPARATOR

Nicotine (4 mg)

Intervention Type DRUG

4 mg nicotine gum in two formulations

Interventions

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Nicotine (2 mg)

2 mg nicotine gum in two formulations

Intervention Type DRUG

Nicotine (4 mg)

4 mg nicotine gum in two formulations

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes