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

September 1, 2015 updated by: INSYS Therapeutics Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test-Reference Sequence
SL spray, followed by SL film
Drug: SL spray
Other Names:
  • Buprenorphine naloxone sublingual spray
Drug: SL film
Other Names:
  • Buprenorphine and naloxone sublingual film
Experimental: Reference-Test Sequence
SL film followed by SL spray
Drug: SL spray
Other Names:
  • Buprenorphine naloxone sublingual spray
Drug: SL film
Other Names:
  • Buprenorphine and naloxone sublingual film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
within 21 days
Time to Cmax (Tmax)
Time Frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
within 21 days
Elimination rate constant
Time Frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
within 21 days
Elimination half-life (T½)
Time Frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
within 21 days
Area under the curve to the final sample with a concentration greater than the limit of quantification (LOQ [AUClast])
Time Frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
within 21 days
Area under the curve extrapolated to infinity (AUCinf)
Time Frame: within 21 days
Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
within 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

INSYS Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Estimate)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS009-15-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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