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CompletedNCT02477267Updated Sep 3, 2015

Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers

A Phase 1 interventional study of SL spray and SL film in Opiate Dependence, sponsored by INSYS Therapeutics Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-03.

Sponsored by INSYS Therapeutics Inc · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Opiate Dependence
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 47 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

INSYS Therapeutics Inc is the lead sponsor of 45 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Meets protocol-specified criteria for qualification and contraception
  • Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion criteria

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    1. the safety or well-being of the participant or study staff;
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
    3. the analysis of results
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Test-Reference Sequence

    SL spray, followed by SL film

    Drug: SL spray · Drug: SL film

  • Experimental
    Reference-Test Sequence

    SL film followed by SL spray

    Drug: SL spray · Drug: SL film

Interventions

  • DrugSL spray

    Also known as: Buprenorphine naloxone sublingual spray

  • DrugSL film

    Also known as: Buprenorphine and naloxone sublingual film

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

    Time frame: within 21 days

  2. Time to Cmax (Tmax)

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

    Time frame: within 21 days

  3. Elimination rate constant

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

    Time frame: within 21 days

  4. Elimination half-life (T½)

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

    Time frame: within 21 days

  5. Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

    Time frame: within 21 days

  6. Area under the curve extrapolated to infinity (AUCinf)

    Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

    Time frame: within 21 days

07

Study locations

1 site
  • Worldwide Clinical Trials Early Phase Services, LLC
    San Antonio, Texas 78217, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02477267
Lead sponsor
INSYS Therapeutics Inc
Responsible party
Sponsor
First posted
Jun 22, 2015
Start date
Jun 2015
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Sep 3, 2015

Study contacts

Giovanni DeCastro
study director · INSYS Therapeutics Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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