CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Nicoderm patch first, then Aveva patchdrug
Likely dose
Not stated in 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/NCT02371850
NCT02371850Phase 4Completed
CompareCT.gov

Determination of Plasma Nicotine Levels After Using Reference and Generic Transdermal Nicotine Patches With and Without Standardized Heat Application in Adult Smokers

University of Maryland, Baltimore·interventional·Posted Feb 26, 2015·Updated Jun 16, 2021

In Brief

A Phase 4 clinical trial evaluating Nicoderm patch first, then Aveva patch for Smoking. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This is a single-dose, Open-label, Non-Randomized, 2-way Crossover Bioequivalence Study to compare nicotine release after heating of a brand name (Nicoderm CQ) and generic (Aveva skin patch) nicotine skin patches in adult smokers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA)

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 26, 2015
Enrollment StartOct 1, 2014
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.3 years ago

Interventions

Nicoderm patch first, then Aveva patchdrug

This is a single group assignment where each of 10 adult smokers completes 4 procedure days using a Nicoderm CQ nicotine patch (2 days) followed by the application of a generic Aveva patch (2 days). For each patch, heating is applied for one hour at hour 4 on the first procedure day and at hour 8 in the second procedure day (2 days per patch, or a total of 4 days per subject).