Nicotine Lozenge Bioequivalence Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

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.

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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

SCREENING

Blinding Strategy

NONE

Study Groups

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Test nicotine lozenge (2 mg)

2 mg test nicotine lozenge to be chewed.

Group Type EXPERIMENTAL

Nicotine (2 mg)

Intervention Type DRUG

2 mg nicotine lozenge in two formulations

Test nicotine lozenge (4 mg)

4 mg test nicotine lozenge to be chewed.

Group Type EXPERIMENTAL

Nicotine (4 mg)

Intervention Type DRUG

4 mg nicotine lozenge in two formulations

Reference nicotine lozenge (2 mg)

2 mg reference nicotine lozenge to be chewed.

Group Type ACTIVE_COMPARATOR

Nicotine (2 mg)

Intervention Type DRUG

2 mg nicotine lozenge in two formulations

Reference nicotine lozenge (4 mg)

4 mg reference nicotine lozenge to be chewed.

Group Type ACTIVE_COMPARATOR

Nicotine (4 mg)

Intervention Type DRUG

4 mg nicotine lozenge in two formulations

Interventions

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Nicotine (2 mg)

2 mg nicotine lozenge in two formulations

Intervention Type DRUG

Nicotine (4 mg)

4 mg nicotine lozenge in two formulations

Intervention Type DRUG

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