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To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers

NCT03543137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-12-04

Study results available
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Summary

This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams \[mg\]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting conditions.

Conditions

  • Tobacco Use Disorder

Interventions

DRUG

Nicotine Prototype Mini lozenge

A single dose of a prototype nicotine 4mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.

DRUG

Nicorette Mini Lozenge

A single dose of a 4 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2018-11-12
Completion
2018-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03543137 on ClinicalTrials.gov