Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01536704 · ClinicalTrials.gov registry record · Phase 1
Nicotine Lozenge Bioequivalence Study
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01536704: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01536704 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01536704, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
Primary Outcome
AUC(0-t) was evaluated using the trapezoid rule.
Interventions
- DRUG Nicotine (2 mg)
- DRUG Nicotine (4 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01536704 record still lists
NCT01536704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Nicotine (2 mg) is the first listed.
NCT01536704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01536704 about?
NCT01536704 is a clinical study titled "Nicotine Lozenge Bioequivalence Study". To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
What is the current status of trial NCT01536704?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01536704?
The interventions under investigation include: Nicotine (2 mg) (DRUG), Nicotine (4 mg) (DRUG).
Who is sponsoring clinical trial NCT01536704?
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 NCT01536704's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia