Trials / Completed
CompletedNCT02477267
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
A Pivotal, Phase 1, Open-Label, Randomized, Crossover, Single-Dose, Comparative Bioavailability Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- INSYS Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SL spray | |
| DRUG | SL film |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2015-06-22
- Last updated
- 2015-09-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02477267. Inclusion in this directory is not an endorsement.