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NCT05024747 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
A Phase 1 study, sponsored by HALEON.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT05024747: Completed Phase 1 study, sponsored by HALEON.
NCT05024747 is a Phase 1 study that has completed, run by HALEON. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05024747, a Phase 1 study, has completed, sponsored by HALEON.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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).
Primary Outcome
Cmax was the highest observed plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed pharmacokinetic (PK) variables, as the dependent variabl
Interventions
- DRUG NicoDerm CQ patch (GSK Dungarvan)
- DRUG NicoDerm CQ (Alza)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2021-10-25 |
| Phase | Phase 1 |
What the finished NCT05024747 record still lists
NCT05024747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which NicoDerm CQ patch (GSK Dungarvan) is the first listed.
NCT05024747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05024747 about?
NCT05024747 is a clinical study titled "A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers". 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).
What is the current status of trial NCT05024747?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-09-01. Estimated completion is 2021-10-25.
What interventions are being tested in trial NCT05024747?
The interventions under investigation include: NicoDerm CQ patch (GSK Dungarvan) (DRUG), NicoDerm CQ (Alza) (DRUG).
Who is sponsoring clinical trial NCT05024747?
This trial is sponsored by HALEON, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05024747's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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