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A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges

NCT00651352 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-11-24

No results posted yet for this study

Summary

Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence.

Conditions

  • Healthy Volunteer Smokers

Interventions

DRUG

4 mg nicotine lozenge

marketed formulation

DRUG

2 mg nicotine lozenge

marketed formulation

DRUG

2 mg nicotine prototype

2 mg

DRUG

4 mg nicotine prototype

4 mg

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-03-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651352 on ClinicalTrials.gov