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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Opiate Dependence

Intervention / Treatment
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* Drug: SL spray
* Drug: SL film


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test-Reference Sequence<br>SL spray, followed by SL film | Drug: SL spray<br> <br> * Other names: Buprenorphine naloxone sublingual spray;Drug: SL film<br> <br> * Other names: Buprenorphine and naloxone sublingual film;|
| Experimental: Reference-Test Sequence<br>SL film followed by SL spray | Drug: SL spray<br> <br> * Other names: Buprenorphine naloxone sublingual spray;Drug: SL film<br> <br> * Other names: Buprenorphine and naloxone sublingual film;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |