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

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SL spray
SL film
Sponsored by
INSYS Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opiate Dependence

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • Worldwide Clinical Trials Early Phase Services, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Test-Reference Sequence

Reference-Test Sequence

Arm Description

SL spray, followed by SL film

SL film followed by SL spray

Outcomes

Primary Outcome Measures

Maximum plasma concentration (Cmax)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time to Cmax (Tmax)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination rate constant
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination half-life (T½)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
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
Area under the curve extrapolated to infinity (AUCinf)
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

Secondary Outcome Measures

Full Information

First Posted
June 18, 2015
Last Updated
September 1, 2015
Sponsor
INSYS Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02477267
Brief Title
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INSYS Therapeutics Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test-Reference Sequence
Arm Type
Experimental
Arm Description
SL spray, followed by SL film
Arm Title
Reference-Test Sequence
Arm Type
Experimental
Arm Description
SL film followed by SL spray
Intervention Type
Drug
Intervention Name(s)
SL spray
Other Intervention Name(s)
Buprenorphine naloxone sublingual spray
Intervention Type
Drug
Intervention Name(s)
SL film
Other Intervention Name(s)
Buprenorphine and naloxone sublingual film
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time Frame
within 21 days
Title
Time to Cmax (Tmax)
Description
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time Frame
within 21 days
Title
Elimination rate constant
Description
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time Frame
within 21 days
Title
Elimination half-life (T½)
Description
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time Frame
within 21 days
Title
Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])
Description
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time Frame
within 21 days
Title
Area under the curve extrapolated to infinity (AUCinf)
Description
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time Frame
within 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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: the safety or well-being of the participant or study staff; the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); the analysis of results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni DeCastro
Organizational Affiliation
INSYS Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Worldwide Clinical Trials Early Phase Services, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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