A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers

PHASE1CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

June 18, 2018

Primary Completion Date

March 24, 2019

Study Completion Date

March 24, 2019

Conditions
Tobacco Use Disorder
Interventions
DRUG

Nicotine Prototype Mini lozenge

A single dose of a prototype nicotine 2mg 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 2 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.

Trial Locations (1)

68502

GSK Investigational Site, Lincoln

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY