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

Phase 1

Completed

• Conditions: Opiate Dependence
• Interventions: Drug: SL spray; Drug: SL film

• Registration Number: NCT02477267
• Lead Sponsor: INSYS Therapeutics Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-22
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test-Reference Sequence	SL spray	SL spray, followed by SL film
Test-Reference Sequence	SL film	SL spray, followed by SL film
Reference-Test Sequence	SL spray	SL film followed by SL spray
Reference-Test Sequence	SL film	SL film followed by SL spray

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	within 21 days	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Time to Cmax (Tmax)	within 21 days	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination rate constant	within 21 days	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Elimination half-life (T½)	within 21 days	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])	within 21 days	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone
Area under the curve extrapolated to infinity (AUCinf)	within 21 days	Categories: buprenorphine, norbuprenorphine, unconjugated naloxone, and total naloxone

Trial Locations

Locations (1)

Worldwide Clinical Trials Early Phase Services, LLC; 🇺🇸 San Antonio, Texas, United States