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NCT03541044 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT03541044: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03541044 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03541044, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment di
Interventions
- DRUG Nicotine Prototype Mini lozenge
- DRUG Nicorette Mini Lozenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2019-03-24 |
| Phase | Phase 1 |
What the finished NCT03541044 record still lists
NCT03541044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Nicotine Prototype Mini lozenge is the first listed.
NCT03541044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03541044 about?
NCT03541044 is a clinical study titled "A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers". 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.
What is the current status of trial NCT03541044?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2018-06-18. Estimated completion is 2019-03-24.
What interventions are being tested in trial NCT03541044?
The interventions under investigation include: Nicotine Prototype Mini lozenge (DRUG), Nicorette Mini Lozenge (DRUG).
Who is sponsoring clinical trial NCT03541044?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03541044's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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