Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02477267 · ClinicalTrials.gov registry record · Phase 1
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT02477267: Completed Phase 1 study, sponsored by INSYS Therapeutics.
NCT02477267 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02477267, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.
Primary Outcome
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Interventions
- DRUG SL spray
- DRUG SL film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT02477267 record still lists
NCT02477267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which SL spray is the first listed.
NCT02477267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02477267 about?
NCT02477267 is a clinical study titled "Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers". The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.
What is the current status of trial NCT02477267?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2015-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02477267?
The interventions under investigation include: SL spray (DRUG), SL film (DRUG).
Who is sponsoring clinical trial NCT02477267?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02477267's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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