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

Opiate Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477267
• Other study ID #: INS009-15-033
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2015
• Last updated: September 1, 2015
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

Drug:
• SL spray

• SL film

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone	within 21 days	No
Primary	Time to Cmax (Tmax)	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone	within 21 days	No
Primary	Elimination rate constant	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone	within 21 days	No
Primary	Elimination half-life (T½)	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone	within 21 days	No
Primary	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	No
Primary	Area under the curve extrapolated to infinity (AUCinf)	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone	within 21 days	No