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Pharmacokinetic Study of 4 mg Nicotine Lozenge.

NCT ID: NCT01669122

Last Updated: 2015-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.

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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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Prototype 1

4mg nicotine lozenge administered orally as a single dose treatment per subject

Group Type EXPERIMENTAL

nicotine

Intervention Type DRUG

4 mg nicotine lozenge experimental

Prototype 2

4mg nicotine lozenge administered orally as a single dose treatment per subject

Group Type EXPERIMENTAL

nicotine

Intervention Type DRUG

4 mg nicotine lozenge experimental

Prototype 3

4mg nicotine lozenge administered orally as a single dose treatment per subject

Group Type EXPERIMENTAL

nicotine

Intervention Type DRUG

4 mg nicotine lozenge experimental

Reference Therapy

4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.

Group Type ACTIVE_COMPARATOR

nicotine

Intervention Type DRUG

4 mg nicotine lozenge experimental

Interventions

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nicotine

4 mg nicotine lozenge experimental

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.

Exclusion Criteria

* inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, India

Site Status

Countries

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India

Other Identifiers

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RH01333

Identifier Type: -

Identifier Source: org_study_id

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