Last updated on April 2019

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

Brief description of study

This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 2 mg) in healthy smokers under fasting conditions.

Detailed Study Description

This study will be a single center, randomized, open label, single dose, two-way crossover in healthy smokers that smoke their first cigarette more than 30 minutes of waking. This study will consist of following Visits: Visit 1 (Screening), Visit 2 (Study Period 1), followed by a Washout period and Visit 3 (Study Period 2). Each participant will be treated with a single dose of the two study treatments (test and reference) in a randomized sequence. Participants will be confined in the study facility for approximately 60 hours during each study session (for 36 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. Participants are to abstain from smoking during the confinement periods and be subject to random measurements of expired carbon monoxide (CO) to confirm abstinence. The CO levels must be 10 parts per million (ppm) throughout the study session. There will be at least 5-day and not more than 7-day clinical furlough period between treatment periods. For each treatment period, the clinical confinement period with restriction of smoking is at least 36 hours prior to dosing.

Clinical Study Identifier: NCT03541044

Contact Investigators or Research Sites near you

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GSK Investigational Site

Lincoln, NE United States

Recruitment Status: Closed

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