CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 37 enrolled
Drug / intervention
Nicotine Prototype Mini lozenge +1 moredrug
Likely dose
Nicotine Prototype Mini lozenge 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03543137
NCT03543137Phase 1Completed
CompareCT.gov

A Single Dose Bioequivalence Study of a 4 mg Prototype Mini Nicotine Lozenge vs 4 mg Nicotine Mini Lozenge (Nicorette Minis) in Healthy Smokers Under Fasting Conditions

GlaxoSmithKline·interventional·Posted Jun 1, 2018·Updated Dec 4, 2019

In Brief

A Phase 1 clinical trial evaluating Nicotine Prototype Mini lozenge and Nicorette Mini Lozenge for Tobacco Use Disorder. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJun 1, 2018
Enrollment StartJun 18, 2018
Primary CompletionNov 12, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.1 years ago

Interventions

Nicotine Prototype Mini lozengedrug

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.

Nicorette Mini Lozengedrug

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.