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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 46 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03541044
The ClinicalTrials.gov registry entry for NCT03541044 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nicotine Prototype Mini lozenge is the first listed.
NCT03541044 reports 0 study locations.
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.
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