At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 22 enrolled
Drug / intervention
NicoDerm CQ patch (GSK Dungarvan) +1 moredrug
Likely dose
NicoDerm CQ patch (GSK Dungarvan) 21 mgfrom 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.
A Randomized, Open Label, Single Center, Single Dose, Two Period, Two Sequence Crossover Bioequivalence Study of 21 mg Nicotine Transdermal Patches (NicoDerm CQ, GSK Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
In Brief
A Phase 1 clinical trial evaluating NicoDerm CQ patch (GSK Dungarvan) and NicoDerm CQ (Alza) for Tobacco Use Disorder. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartSep 2021
Primary CompletionOct 2021
TodayJul 2026
First PostedAug 27, 2021
Enrollment StartSep 1, 2021
Primary CompletionOct 25, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.8 years ago
Interventions
NicoDerm CQ patch (GSK Dungarvan)drug
A single patch of a NicoDerm CQ (GSK Dungarvan) 21 mg per system of 22 centimeter square (cm\^2) surface area will be placed topically.
NicoDerm CQ (Alza)drug
A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm\^2 surface area will be placed topically.