NCT02477267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

June 18, 2015

Last Update Submit

September 1, 2015

Conditions

Opiate Dependence

Outcome Measures

Primary Outcomes (6)

  • Maximum plasma concentration (Cmax)

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

    within 21 days

  • Time to Cmax (Tmax)

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

    within 21 days

  • Elimination rate constant

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

    within 21 days

  • Elimination half-life (T½)

    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])

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

    within 21 days

  • Area under the curve extrapolated to infinity (AUCinf)

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

    within 21 days

Study Arms (2)

Test-Reference Sequence

EXPERIMENTAL

SL spray, followed by SL film

Drug: SL sprayDrug: SL film

Reference-Test Sequence

EXPERIMENTAL

SL film followed by SL spray

Drug: SL sprayDrug: SL film

Interventions

SL sprayDRUG
Also known as: Buprenorphine naloxone sublingual spray
Reference-Test SequenceTest-Reference Sequence
SL filmDRUG
Also known as: Buprenorphine and naloxone sublingual film
Reference-Test SequenceTest-Reference Sequence

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Giovanni DeCastro

    INSYS Therapeutics Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 22, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-08

Locations

US(1)